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[COMMITTEE PRINT] 



LEGISLATIVE HISTORY OF THE TOXIC 
SUBSTANCES CONTROL ACT 

TOGETHER WITH 

A SECTION-BY-SECTION INDEX 

PREPARED BY THE 

ENVIRONMENT AND NATURAL RESOURCES 
POLICY DIVISION 

OF THE 

LIBRARY OF CONGRESS 

FOH THE 

HOUSE COMMITTEE ON 
INTERSTATE AND FOREIGN COMMERCE 




Printed for the use of the 
Committee on Interstate and Foreign Commerce 



[COMMITTEE PRINT] 



LEGISLATIVE HISTORY OF THE TOXIC 
SUBSTANCES CONTROL ACT 

TOGETHER WITH 

A SECTION-BY-SECTION INDEX 

PREPARED BY THE 

EXVIROXMEXT AXD XATURAL RESOUECES 
POLICY DIVISIOX 

OF THE 

LIBRARY OF COXGRESS 

FOR THE 

HOUSE COMMITTEE ON 
INTERSTATE AND FOREIGN COMMERCE 




DECEMBER 1976 



Printed for the use of the 
Committee on Interstate and Foreign Commerce 



79-313 o 



U.S. GOVERNMENT PRINTING OFFICE 
WASHINGTON : 1976 



COMMITTEE ON INTERSTATE AND FOREIGN COMMERCE 



HARLEY O. STAGGERS, 
JOHN E. MOSS, California 
JOHN D. DINGELL, Michigan 
PAUL G. ROGERS, Florida 
LIONEL VAN DEERLIN, California 
FRED B. ROONEY, Pennsylvania 
JOHN M. MURPHY, New York 
DAVID E. SATTERFIELD III, Virginia 
BROCK ADAMS, Washington 
W. S. (BILL) STUCKEY, Jr., Georgia 
BOB ECKHARDT, Texas 
RICHARDSON PREYER, North Carolina 
JAMES W. SYMINGTON, Missouri 
CHARLES J. CARNEY, Ohio 
RALPH H. METCALFE, Illinois 
GOODLOE E. BYRON, Maryland 
JAMES H. SCHEUER, New York 
RICHARD L. OTTINGER, New York 
HENRY A. WAXMAN, California 
ROBERT (BOB) KRUEGER, Texas 
TIMOTHY E. WIRTH, Colorado 
PHILIP R. SHARP, Indiana 
WILLIAM M. BRODHEAD, Michigan 
JAMES J. FLORIO, New Jersey 
ANTHONY TOBY MOFFETT, Connecticut 
JIM SANTINI, Nevada 
ANDREW MAGUIRE, New Jersey 
MARTIN A. RUSSO, Illinois 



West Virginia, Chairman 

SAMUEL L. DEVINE, Ohio 

JAMES T. BROYHILL, North Carolina 

TIM LEE CARTER, Kentucky 

CLARENCE J. BROWN, Ohio 

JOE SKUBITZ, Kansas 

JAMES M. COLLINS, Texas 

LOUIS PREY, Jr., Florida 

JOHN Y. McCOLLISTER, Nebraska 

NORMAN F. LENT, New York 

H. JOHN HEINZ III, Pennsylvania 

EDWARD R. MADIGAN, Illinois 

CARLOS J. MOORHEAD, California 

MATTHEW J. RINALDO, New Jersey 

W. HENSON MOORE, Louisiana 



W. E. Williamson, Clerk 
Kenneth J. Painter, Assistant Clerk 



Professional Staff 

Charles B. Curtis 
Lee S. Hyde 
Elizabeth Harrison 
Jeffrey H. Schwartz 

Margot Dinneen 
Lewis E. Berry, Minority Counsel 



William P. Adams 
Robert R. Nordhaus 
Brian R. Moir 
Karen Nelson 



LETTER OF TRANSMITTAL 



The Library of Coxgress, 
Congressional Research Service, 
Washington^ D.C., November 15^ 1976. 

Hon. PLvRLEY O. Staggers, 

Chainnaru Committee on Interstate ami Foreign Commerce^ U.S. 
House of Represe7itatives^ Washington^ B.C. 
Dear ^Ir. Chairman : In response to your request, we liave prepared 
a legislative history of the Toxic Substances Control Act, Public Law 
94-469. 

This docuinorit contains the major bills, reports, and debates which 
comprise the action of the 94th Congress concerning the act. Appen- 
dices contain a report of the (^ouncil on P^nvironmental Quality which 
originally proposed this legislation and a bibliography of Congres- 
sional documents concerning Toxic Substances Control legislation 
from 1971 to 1976. A section-by-section index is included to permit 
easier access to provisions of concern. 

The history should be of considerable aid to legislatoi*s, public offi- 
cials, industries, and the general public who are affectx^d by this act 
and who wish to understand the Congressional intent of Public Law 
94-469. 

The author of this report was John E. Plodgett, Analyst, of tlie 
Environment and Natural Resources Policy Division. 

We hope this document will serve your Committee's needs for a his- 
tory of Congressional action on this act. 
Sincerely, 

Norman Beckman, 

Acting Director. 

(Ill) 



FOREWORD 



This committee print compiles the siofnificant documents and de- 
bates comprisintr the legislative history of S. 3149, the Toxic Sub- 
stances Control Act. signed into law (Public Law 94-^69) on Octo- 
ber 11, 1976. 

Congressional activity concerning this act extends back to 1971, 
when the Council on Environmental Quality published a report "Toxic 
Substances." This report is reprinted as an appendix. The major Con- 
gressional documents and debates of the full ])eriod of action on toxic 
substances control — 1971 to 1976 — are listed in the bibliography. 

In the debates, references to specific sections are in boldface type; 
these refer to the section numbers of the bill under consideration. A 
table at the beginning of the index correlates the section numbers of 
the major bills and of the act (all of which are identical except for the 
last few sections). 

Joiix E. Blodgett, 
Analysts En vironmenf and Xafural 

Resources Policy Division. 

(V) 



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by the Internet Archive 








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CONTENTS 



Page 



Chapter I : Toxic Substances Control Act 2 

Public Law 94-469 3 

President's approval 53 

Chapter II : S. 3149 55 

S. 3149 57 

Senate Report No. 94-698 155 

Senate debate, March 26, 1976 207 

Chapter III: H.R. 14032 295 

H.R. 14032 297 

House Report No. 94-1341 407 

House debate, Aujjust 23. 1976 517 

Chapter IV : Conference Report 665 

Conference report. House Report No. 94-1679 667 

Senate consideration of conference report, September 28, 1976 721 

House consideration of conference reiMirt. September 28, 1976 741 

Appendix I : Council on KInvironmental Quality report — Toxic Suhfitanccs 

(1971) 755 

Appendix II : Bibliography — Congressional documents 1971-1970 789 

Section-by-section index : 

Table comparing? sections of Public Law 94—169, H.R. 14032, and 

S. 3149 795 

Index 795 



(vn) 



CHAPTER I 



TOXIC substancp:s control act- 
public LAW 94-469 



3 



PUBLIC LAW 94-^9— OCT. 11, 1976 90 STAT. 2003 



Public Law 94-469 
94th Congress , 



An Act 



To regulate commerce and protect human health and the environment by Oct. 11, 1976 
requiring testing and necessary use restrictions on certain chemical substances, rg 31 401 

and for other purposes. ^ ' ^ 

Be it enacted hy the Senate and Ilouae of Representatives of the 
Unitt d States of Arntrh a in Congress assembled^ Toxic Substances 

SECTION 1. SHORT TITLE AND TABLE OF CONTENTS. irUSC 2^)^ 

This Act may be cited as the "Toxic Substances Control Act". note. 

TABLE OF CONTENTS 

Sec, 1. Short title and table of contents. 
Sec. 2. Findings, policy, and intent. 
Sec. 3. Definitions. 

Sei*. 4. Testing of diemical substances and mixtures. 
Sec. 5. Manufacturing and i)rocessing notices. 

Se<-. 6. Reguhition of hazardoiis chemical substances and mixtures. 
Sec. 7. Imminent hazards. 

Sec. 8. Reporting and retention of information. 
Sec. 9. Relationship to other Federal laws. 

Sec. 10. Research, deveh)pment, collection, dissemination, and utilization of data. 
Sec. 11. Inspections and subpoenas. 
Sec. VI. Exports. 

Sec. 13. Entry into customs territory of the United States. 
Sec. 14. Di.^dosure of data. 
Sec. 15. Prohibited acts. 
Sec. 16. Penalties. 

Sec. 17. Specific enforcement and seizure. 

Sec. 18. I'reemption. 

Se<'. 19. Judicial review. 

Sec. 20. Citizens' civil actions. 

Sec. 21. Citizens' petitions. 

Sec. 22. National defense waiver. 

Sec. 23. Employee protection. 

Sec. 24. Employment effects. 

Sec. 25. Studies. 

Sec. 26. Administration of the Act. 

Sec. 27. Development and evaluation of test methods. 

Sec. 28. State programs. 

Sec. 29. Authorization for appropriations. 

Sec. 30. Annual report. 

Sec. 31. Effective date. 

SEC. 2. FINDINGS, POLICY, AND INTENT. 

(a) Findings.— The Congress finds tliat— 15 USC 2601. 

(1) human beings and the environment are being exposed each 
year to a large number of chemical substances and mixtures; 

(2) among the many chemical substances and mixtures which 
are constantly being developed and produced, there are some 
whose manufacture, processing, distribution in commerce, use, or 
disposal may present an unreasonable risk of injury to health or 
the environment; and 

(3) the effective regulation of interstate commerce in such 
chemical substances and mixtures also necessitates the regulation 
of intrastate commerce in such chemical substances and mixtures. 

(b) Policy. — It is the policy of the United States that — 

(1) adequate data should be developed with respect to the effect 
of chemical substances and mixtures on health and the environ- 



4 



90 STAT. 2004 PUBLIC LAW 94-469— OCT. 11, 1976 

ment and that the development of such data should be the respon- 
sibility of those who manufacture and those who process such 
chemical substances and mixtures ; 

(2) adequate authority should exist to regulate chemical sub- 
stances and mixtures which present an unreasonable risk of injury 
to health or the environment, and to take action with respect to 
chemical substances and mixtures which are imminent hazards; 
and 

(3) authority over chemical substances and mixtures should be 
exercised in such a manner as not to impede unduly or create 
unnecessary economic barriei-s to technological innovation wliile 
fulfilling the primary purpose of this Act to assure that such inno- . 
vation and commerce in such chemical substances and mixtures 
do not present an unreasonable risk of injury to health or the 
environment. 

(c) Intent of Congress. — It is the intent of Congress that the 
Administrator shall carry out this Act in a reasonable and prudent 
manner, and that the Administrator shall consider the environmental, 
economic, and social impact of any action the Administrator takes or 
proposes to take under this Act. 
SEC. 3. DEFINITIONS. 
15 use 2602. As used in this Act: 

(1) the term "Administrator" means the Administrator of the 
Environmental Protection Agency. 

(2) (A) Except as provided in subparagraph (B), the term "chem- 
ical substance" means any organic or morganic substance of a particu- 
lar molecular identity, including — 

(i) any combination of such substances occurring in whole or 
in part as a result of a chemical reaction or occurring ki nature, 
and 

(ii) any element or uncombined radical. 
( B ) Such term does not include — 

(i) any mixture, 

(ii) any pesticide (as defined in the Federal Insecticide, Fungi- 
7 use 136 note. cide, and Rodenticide Act) when manufactured, processed, or 

distributed in commerce for use as a pesticide, 

(iii) tobacco or any tobacco product, 

(iv) any source material, special nuclear material, or byproduct 
material (as such terms are defined in the Atomic Energy Act 

42 use 2011 of 1954 and regulations issued under such Act), 

°ot«- (v) any article the sale of which is subject to the tax imposed 

26 use 4181. by section 4181 of the Internal Revenue Code of 1954 (deter- 

mined without regard to any exemptions from such tax provided 
26 use 4182, by section 4182 or 4221 or any other provision of such Code) , and 

"^221. (vi) any food, food additive, drug, cosmetic, or device (as such 

terms are defined in section 201 of the Federal Food, Drug, and 
21 use 321. Cosmetic Act) when manufactured, processed, or distributed in 

commerce for use as a food, food additive, drug, cosmetic, or 
device. 

The term "food" as used in clause (vi) of tliis subparagraph includes 
poultry and poultry products (as defined in sections 4(e) and 4(f) 
21 use 453. of the Poultry Products Inspection Act) , meat and meat food prod- 
21 use 601. ucts (as defined in section of the Federal Meat Inspection Act), 
and eggs and egg products (as defined in section 4 of the Egg Prod- 
21 use 1033. ucts Insnection Act) . 

(3) The term "commerce" means trade, traffic, transportation, or 
other commerce (A) between a place in a State and any place outside 



5 



PUBLIC LAW 94-469— OCT. 11, 1976 90 STAT. 2005 

of sucli State, or (B) which affects trade, traffic, transportation, or 
commerce described in clause ( A) . 

(4) The terms "distribute in commerce'* and "distribution in com- 
merce" when used to describe an action taken with respect to a chem- 
ical substance or mixture or article containing a substance or mixture 
mean to sell, or the sale of, the substance, mixture, or article in com- 
merce ; to introduce or deliver for introduction into commerce, or the 
introduction or delivery for introduction into commerce of, the sub- 
stance, mixture, or article ; or to hold, or the holding of, the substance, 
mixture, or article after its introduction into commerce. 

(5) The term "environment" includes water, air, and land and the 
interrelationship which exists among and between w^ater, air, and land 
and all living things. 

(6) The tenn "health and safety study" means any study of any 
effect of a chemical substance or mixture on health or the environ- 
ment or on both, including underlying data and epidemiological 
studies, studies of occupational exposure to a chemical substance or 
mixture, toxicological, clinical, and ecological studies of a chemical 
substance or mixture, and any test performed pursuant to this Act. 

(7) The term 'Snanufacture" means to import into the customs 
territory of the United States (as defined in general headnote 2 of 

the Tariff Schedules of the United States), prepuce, or manufacture. 19 USC 1202. 

(8) The term "mixture" means any combination of two or more 
chemical substances if the combination does not occur in nature and 
is not, in whole or in part, the result of a chemical reaction ; except 
that such term does include any combination which occurs, in whole 
or in part, as a result of a chemical reaction if none of the chemical 
substances comprising the combination is a new chemical substance 
and if the combination could have been manufactured for commer- 
cial purposes without a chemical reaction at the time the chemical 
substances comprising the combination were combined. 

(9) The term "new chemical substance" means any chemical sub- 
stance which is not included in the chemical substance list compiled 

and published under section 8(b). Post, p. 2027. 

(10) The term "process" means the preparation of a chemical sub- 
stance or mixture, after its manufacture, for distribution in 
commerce — 

(A) in the same form or physical state as, or in a different 
form or physical state from, that in which it was received by the 
person so preparing such substance or mixture, or 

(B) as part of an article containing the chemical substance 
or mixture. 

(11) The term "processor" means any person who processes a chemi- 
cal substance or mixture. 

(12) The term "standards for the development of test data" means 
a prescription of — 

(A) the— 

(i) health and environmental effects, and 

(ii) information relating to toxicity, persistence, and other 
characteristics which affect health and the environment, 

for which test data for a chemical substance or mixture are to 
be developed and any analysis that is to be performed on such 
data, and 

(B) to the extent necessary to assure that data respecting such 
effects and characteristics are reliable and adequate — 

(i) the manner in which such data are to be developed, 

(ii) the specification of any. test protocol or methodology 
to be employed in the development of such data, and 



6 



90 STAT. 2006 



PUBUC LAW 94^469— OCT. 11, 1976 



15 use 2603. 



Rules. 



Standards for 
development of 
test data. 
Data, submittal to 
Administrator. 



(iii) such other requirements as are necessary to provide 
such assurance. 

(13) The term "State" means any State of the United States, the 
District of Columbia, the Commonwealth of Pueiix) Rico, the Virgin 
Islands, Guam, the Canal Zone, American Samoa, the Northern 
Mariana Islands, or any other territory or possession of the United 
States. 

(14) The term "United States", when used in the geographic sense, 
means all of the States. 

SEC. 4. TESTING OF CHEMICAL SUBSTANCES AND MIXTURES. 

(a) Testing Requirements. — If the Administrator finds that — 

(1) (A)(i) the manufacture, distribution in commerce, proc- 
essing, use, or disposal of a chemical substance or mixture, or that 
any combination of such activities, may present an unreasonable 
ri k of injury to health or the environment, 

(ii) there are insufficient data and experience upon which the 
effects of such manufacture, distribution in commerce, processing, 
use, or disposal of such substance or mixture or of any combina- 
tion of such activities on health or the environment can reason- 
ably be determined or predicted, and 

(iii) testing of such substance or mixture with respect to such 
effects is necessary to develop such data ; or 

(B) (i) a chemical substance or mixture is or will be produced 
in substantial quantities, and (I) it enters or may reasonably be 
anticipated to enter the environment in substantial quantities or 
(II) there is or may be significant or substantial human exposure 
to such substance or mixture, 

(ii) there are insufficient data and experience upon which the 
effects of the manufacture, distribution in commerce, processing, 
use, or disposal of such substance or mixture or of any combina- 
tion of such activities on health or the environment can reason- 
ably be determined or predicted, and 

(iii) testing of such substance or mixture with respect to such 
effects is necessary to develop such data ; and 

(2) in the case of a mixture, the effects which the mixture's 
manufacture, distribution in commerce, processing, use, or dis- 
posal or any combination of such activities may have on health or 
the environment may not be reasonably and more efficiently deter- 
mined or predicted by testing the chemical substances which com- 
prise the mixture ; 

the Administrator shall by rule require that testing be conducted on 
such substance or mixture to develop data with respect to the health 
and environmental effects for which there is an insufficiency of data 
and experience and which are relevant to a determination that the 
manufacture, distribution in commerce, processing, use, or disposal 
of such substance or mixture, or that any combination of such activities, 
does or does not present an unreasonable risk of injury to health or 
the environment. 

(b) (1) Testing Requirement Rule. — A rule under subsection (a) 
shall include — 

(A) identification of the chemical substance or mixture for 
which testing is reauired under the rule, 

(B) standards for the development of test data for such sub- 
stance or mixture, and 

(C) with respect to chemical substances which are not new 
chemical substances and to mixtures, a specification or the period 
(which period may not be of unreasonable duration) within 



7 



PUBLIC LAW 94-469— OCT. 11, 1976 90 STAT. 2007 

which the persons required to conduct the testing shall submit to 
the Administrator data developed in accordance with the stand- 
ards referred to in subparagraph (B). 
In determining the standards and period to be included, pursuant to 
subparagraphs (B) and (C), ^n a rule under subsection (a), the 
Administrator's considerations shall include the relative costs of the 
various test protocols and methodologies which ma^' be required under 
the rule and the reasonably foreseeable availability of the facilities 
and personnel needed to perform the testing required under the rule. 
Any such rule may require the submission to the Administrator of pre- 
liminary data during the period prescribed under subparagraph (C). 

(2) (A) The health ana environmental effects for which standards 
for the development of test data may be prescribed include carcino- 
genesis, mutagenesis, teratogenesis, behavioral disorders, cumulative 
or synergistic effects, and any other effect which may present an unrea- 
sonable risk of injury to health or the environment. The chai-acteristics 
of chemical substances and mixtures for which such standanls may 
be prescribed include persistence, acute toxicity, subacute toxicity, 
chronic toxicity, and any other characteristic which may present such 
a risk. The methodologies that may be prescribed in such standards 
include epidemiologic studies, serial or hierarchical tests, in vitro tests, 
and whole animal tests, except that before prescribing epidemiologic 
studies of employees, the Administrator shall consult with the Director 
of the National Institute for Occupational Safety and Health. 

(B) From time to time, but not less than once each 12 months, the Review of 
Administrator shall review the adequacy of the standards for develop- standards, 
ment of data prescribed in rules under subsection (a) and shall, if 
necessary, institute proceedings to make appropriate revisions of such 
standards. 

(3) (A) A rule under subsection (a) respecting a chemical substance 
or mixture shall require the })ersons described in subparagraph (B) 
to conduct tests and submit data to the Administrator on such sub- 
stance or mixture, except that the Administrator may permit two or 
more of such })ei-sons to designate one such pei-son or a qualified ihiixi 
party to conduct such tests and submit such data on behalf of the per- 
sons making the designation. 

(B) The following i>ersons shall be required to conduct tests and 
submit data on a chemical substance or mixture subject to a rule under 
subsection (a) : 

(i) Each person who manufactures or intends to manufacture 
such substance or mixture if the Administrator makes a finding 
described in subsection (a) (1) (A) (ii) or (a) (1) (B) (ii) with 
respect to the manufacture of such substance or mixture. 

(ii) Each person who processes or intends to process such sub- 
stance or mixture if the Administrator makes a finding described 
in subsection (a) (1) (A) (ii) or (a) (1) (B) (ii) with respect to 
the processing of such substance or mixture. 

(iii) Each person who manufactures or processes or intends to 
manufacture or process such substance or mixture if the Adminis- 
trator makes a nnding described in subsection (a) (1) (A) (ii) or 
(a) (1) (B) (ii) with respect to the distribution in commerce, use, 
or disposal of such substance or mixture. 

(4) Any rule under subsection (a) requiring the testing of and 
submission of data for a particular chemical substance or mixture 
shall expire at the end of the reimbursement period (as defined in sub- 
section (c)(3)(B)) which is applicable to test data for such substance 
or mixture unless the Administrator repeals the rule before such date; 



8 



90 STAT. 2008 



PUBUC LAW 94-469— OCT. 11, 1976 



Oral presentatioi 
and written 
submissions. 
TranscripL 
Publication. 



Application. 



Fair and 
equitable 
reimbursement 



Rules. 



and a rule under subsection (a) requiring the testing of and submission 
of data for a category of chemical substances or mixtures shall expire 
with respect to a chemical substance or mixture included in the cate- 
gory at the end of the reimbursement period (as so defined) which is 
applicable to test data for such substance or mixture unless the Admin- 
istrator before such date repeals the application of the rule to such 
substance or mixture or repeals the rule. 

(5) Rules issued under subsection (a) (and any substantive amend- 
ment thereto or repeal thereof) shall be promulgated pursuant to 
section 553 of title 5, United States Code, except that (A) the Admin- 
istrator sliall give interested persons an opportunity for the oral pres- 
entation of data, views, or arguments, in addition to an opportunity to 
make written submissions; (B) a transcript shall be made of any oral 
presentation; and (C) the Administrator shall make and publish with 
the rule the findings described in paragraph (1) (A) or (1)(B) of 
subsection (a) and, in the case of a rule respecting a mixture, the 
finding described in paragraph (2) of such subsection. 

(c) Exemption. — (1) Any person required by a rule under subsec- 
tion (a) to conduct tests and submit data on a chemical substance or 
mixture may apply to the Administrator (in such form and manner 
as the Administrator shall prescribe for an exemption from such 
requirement. 

(2) If, upon receipt of an application under paragraph (1), the 
Administrator determines that — 

(A) the chemical substance or mixture with respect to which 
such application was submitted is equivalent to a chemical sub- 
stance or mixture for which data has been submitted to the Admin- 
istrator in accordance with a rule under subsection (a) or for 
which data is being developed pursuant to such a rule, and 

(B) submission of data by the applicant on such substance or 
mixture would be duplicative of data which has been submitted 
to the Administrator in accordance with such rule or which is 
being developed pursuant to such rule, 

the Administrator shall exempt, in accordance with paragraph (3) 
or (4), the applicant from conducting te^ts and submitting data on 
such substance or mixture under the rule with respect to which such 
application was submitted. 

(3) (A) If the exemption under paragraph (2) of any person from 
the requirement to conduct tests and submit t^t data on a chemical 
substance or mixture is granted on the basis of the existence of previ- 
ouslv submitted test data and if such exemption is granted during the 
reimbursement period for such test data (as prescribed by subpara- 
graph (B) ), then (unless such person and the persons referred to in 
clauses (i) and (ii) agree on the amount and method of 'reimburse- 
ment) the Administrator shall order the person granted the exemption 
to provide fair and equitable reimbursement (in an amount deter- 
mined under rules of the Administrator ) — 

(i) to the person who previously submitted sUch test data, for 
a portion of the costs incurred by such person i^ complying with 
the requirement to submit such data, and 

(ii) to any other person who h^ been required under this sub- 
paragraph to contribute with respect to such costs, for a portion 
of the amount such person was required to contribute. 

In promulgating rules for the determination of fair and equitable 
reimbursement to the persons described in clauses (i) and (ii) for 
costs incurred with respect to a chemical substance or mixture, the 
Administrator shall, after consultation with the Attorney General 



9 



PUBLIC LAW 94^9— OCT. 11, 1976 90 STAT. 2009 

and the Federal Trade Commission, consider all relevant factors, 
including the effect on the competitive position of the person required 
to provide reimbursement in relation to the person to be reimbursed 
and the share of the market for such substance or mixture of the per- 
son required to provide reimbursement in relation to the share of such 
market of the persons to be reimbursed. An order under this sub- 
paragraph shall, for purposes of judicial review, be considered final 
agency action. 

(B) For purposes of subparagraph (A), the reimbursement period Reimbursement 
for any test data for a chemical substance or mixture is a perioa — period. 

(i) beginning on the date such data is submitted in accordance 
with a rule promulgated under subsection (a) , and 

(ii) ending — 

(I) five years after the date referred to in clause (i), or 

(II) at the expiration of a period which begins on the date 
referred to in clause (i) and which is equal to the period 
which the Administrator determines was necessary to develop 
such data, 

whichever is later. 
(4) (A) If the exemption under paragraph (2) of any person from 
the requirement to conduct tests and submit test data on a chemical 
substance or mixture is granted on the basis of the fact that test data 
is being developed by one or more persons pursuant to a rule promul- 
gated under subsection (a), then (unless such person and the persons 
referred to in clauses (i) and (ii) agree on the amount and method 
of reimbursement) the Administrator shall order the person granted 
the exemption to provide fair and equitable reimbursement (in an 
amount determined under rules of the Administrator) — 

(i) to each such person who is developing such test data, for a 
portion of the costs incurred by each such person in cx)mplying 
with such rule, and 

(ii) to any other person who has been required under this sub- 
paragraph to contribute with respect to the costs of complying 
with such rule, for a portion of the amoimt such person was 
required to contribute. 

In promulgating rules for the determination of fair and eauitable 
reimbursement to the persons described in clauses (i) and (ii) for 
costs incurred with respect to a chemical substance or mixture, the 
Administrator shall, after consultation with the Attorney General and 
the Federal Trade Commission, consider the factors described in the 
second sentence of paragraph (3) (A). An order under this subpara- 
graph shall, for purposes of judicial review, be considered final agency 
action. 

(B) If any exemption is granted under paragraph (2) on the basis 
of the fact that one or more persons are developing test data pursuant 
to a rule promulgated under subsection (a) and if after such exemp- 
tion is granted the Administrator determines that no such person has 
complied with such rule, the Administrator shall (i) after providing 
written notice to the person who holds such exemption and an oppor- 
tunity for a hearing, by order terminate such exemption, and (ii) 
notify in writing such person of the requirements of the rule with 
respect to which such exemption was granted. 

(d) Notice. — Upon the receipt of any test data pursuant to a rule Publication in 
under subsection (a), the Administrator shall publish a notice of the Federal Register, 
receipt of such data in the Federal Register within 15 days of its 
receipt. Subject to section 14, each such notice shall (1) identify the 
chemical substance or mixture for which data have been received; 
(2) list the uses or intended uses of such substance or mixture and the 



79-313 O - 77 - 2 



10 



90 STAT. 2010 



PUBLIC LAW 94-469— OCT. 11, 1976 



Post, p. 2034. 

Committee to 
make 

recommendations 
to 

Administrator. 



Recommenda- 
tions, list of 
chemical 
substances and 
mixtures. 



Publication in 
Federal Register; 
transmitt^^ to 
Administrator. 



List revision, 
publication in 
Federal Register. 



inforination required by the applicable standards for the development 
of test data; and (3) describe the nature of the test data developed. 
Except as otherwise provided in section 14, such data shall be made 
available by the Administrator for examination by any person. 

(e) Priority List. — (1) (A) There is established a committee to 
make recommendations to the Administrator respecting the chemical 
substances and mixtures to which tlie Administrator should give 
priority consideration for the promulgation of a rule under subsec- 
tion (a). In making such a recommendation with respect to any chem- 
ical substance or mixture, the committee shall consider all relevant 
factors, including — 

(i) the quantities in which the substanceior mixture is or will 
be manufactured, 

(ii) the quantities in which the substance or mixture enters or 
will enter the environment, 

(iii) the number of individuals who are or will be exposed to the 
substance or mixture in their places of employment and the dura- 
tion of such exposure, 

(iv) the extent to which human beings are or will be exposed to 
the substance or mixture, 

(v) the extent to which the substance or mixture is closely 
related to a cliemical substance or mixture which is known to 
present an unieasonable risk of injury to health or the environ- 
ment, 

(vi) the existence of data concerning the effects of the substance 
or mixture on health or. the environment, 

(vii) the extent to which testing of the substance or mixture 
may result in the development of data upon which the effects of 
the substance or mixture on health or the environment ^an rea- 
sonably be determined or predicted, and 

(viii) the reasonably foreseeable availability of facilities and 
personnel for performing testing on the substance or mixture. 

The recommendations of the committee shall be in the form of a list 
of chemical substances and mixtures which shall be set forth, either by 
individual substance or mixture or by groups of substances or mix- 
tures, in the order in which the committee determines the Administra- 
tor should take action under subsection (a) with respect to the 
substances and mixtures. In establishing such list, the committee shall 
give priority attention to those chemical substances and mixtur 
which are known to cause or contribute to or which are suspected 
causing or contributing to cancer, gene mutations, or birth defects. The 
committee shall designate chemical substances and mixtures onj^Ke list 
with respect to which the committee determines the Administrator 
should, within 12 months of the date on which such substances and 
mixtures are first designated, initiate a proceeding under subsection 
(a). The total number of chemical substances and mixtures on the list 
which are designated under the preceding sentence may not, at any 
time, exceed .50. 

(B) As soon as practicable but not later than nine months after 
the effective date of this Act, the connnittee shall publish in the Fed- 
eral Register and transmit to the Administrator the list and designa- 
tions required by subparagraph (A) together with the reasons for the 
committee's inclusion of each chemical substance or mixture on the list. 
At least every six months after the date of the transmission to the Ad- 
ministrator (if the list pursuant to the precoeding sentence, the commit- 
tee shall make such revisions in the list as it determines to be ne<:essary 
and shall transmit them to the Administrator together witli the com- 
mittee's reasons for the revisions. Upon receipt of any such revision, 



11 



PUBLIC LAW 94-469— OCT. 11, 1976 



90 STAT. 2011 



the Administrator shall publish in the Federal Register the list with 
such revision, the reasons for such revision, and the designations made 
under subparagraph ( A) . The Administrator shall provide reasonable Comments, 
opportunity to any interested person to file with the Administrator 
written comments on the committee's list, any revision of such list 
by the committee, and designations made by the committee, and shall 
make such comments available to the public. Within the 12-month Publication in 
period beginning on the date of the first inclusion on the list of a Federal Register, 
chemical substance or mixture designated by the committee under sub- 
paragraph (A) the Administrator shall with respect to such chemical 
substance or mixture either initiate a rulemaking proceeding under 
subsection (a) or if such a proceeding is not initiated within such 
period, publish in the Federal Register the Administrator's reason for 
not initiating such a proceeding. 

(2) (A) The committee established by paragraph (1) (A) shall con- Membership, 
sist of eight membei"S as follows : 

(i) One member appointed by the Administrator from the 
Environmental Protection Agency. 

(ii) One member appointed by the Secretary of Labor from 
officers or employees of the Department of I^bor engaged in the 
Secretary's activities under the Occupational Safety and Health 
Act of 1970. 

(iii) One member appointed by the Chairman of the Council 
on Environmental Quality from, the Council or its officer's or 



(iv) One member appointed by the Director of the National 
Institute for Occupational Safety and Health from officers or 
employees of the Institute. 

(v) One member appointed by the Director of the National 
Institute of Environmental Health Sciences from officers or 
employees of the Institute. 

(vi) One member appointed by the Director of the National 
Cancer Institute from officers or employees of the Institute. 

(vii) One member appointed by the Director of the National 
Science Foundation from officers or employees of the Foundation. 

(viii) One member appointed by the Secretary of Commerce 
from officere or employees of the Department of Commerce. 

(B) (i) An appointed member may designate an individual to serve 
on the committee on the member*s behalf. Such a designation may be 
made only with the approval Of the applicable appointing authority 
and only if the individual is from the entity from which the member 
was appointed.. 

(ii) No individual may serve as a member of the committee for more 
than four years in the aggregate. If any member of the committee 
leaves the entity from which the member was appointed, such member 
ma^ not continue as a member of the committee, and the member's 
position shall be considered to be vacant. A vacancy in the committee 
shall be filled in the same manner in which the original appointment 
was made. \ 

(iii) Initial appointments to the committee shall be made not later 
than the 60th day after the effective date of this Act. Not later than 
the 90th day after such date the members of the committee shall hold a 
meeting for the selection of a chairperson from among their number. 

(C) (i) No member of the committee, or designee of such member, 
shall accept employment or compensation from any person subject to 
any requirement of this Act or of any rule promulgated or order issued 
thereunder, for a period of at least 12 months after termination of 
service on the committee. 

89-139 (360) O - 76 — 2 




12 



90 STAT. 2012 PUBLIC LAW 94-469— OCT. 11, 1976 

(ii) No person, while serving as a member of the committee, or des- 
ignee of such member, may own any stocks or bonds, or have any 
pecuniary interest, of substantial value in any person engaged in the 
manufacture, processing, or distribution in commerce of any chemical 
substance or mixture subject to any requirement of this Act or of any 
rule promulgated or order issued thereunder. 

(iii) The Administrator, acting through attorneys of the Environ- 
mental Protection AgeQcy, or the Attorney General may bring an 
action in the appropriate district court of the United States to restrain 
any violation of this subparagraph. 

(D) The Administrator shall provide the committee such admin- 
istrative support services as may be necessary to enable the committee 
to carry out its function under this subsection. 

(f ) Required Actions. — Upon the receipt of — 

(1) any test data required to be submitted under this Act, or 

(2) any other information available to the Administrator, 
which indicates- to the Administrator that there may be a reasonable 
basis to conclude that a chemical substance or mixture presents or will 
present a significant risk of serious or widespread harm to human 
beings from cancer, gene mutations, or birth defects, the Administra- 
tor shall, within the 180-day period beginning on the date of the receipt 
of such data or information, initiate appropriate action under section 
5, 6, or 7 to prevent or reduce to a sufficient extent such risk or publish 
in the Federal Register a finding that such risk is not unreasonable. For 
good cause shown the Administrator may extend such period for an 

Publication in additional period of not more than 90 days. The Administrator shall 
Federal Register, publish in the Federal Register notice of any such extension and the 
reasons therefor. A finding by the Administrator that a risk is not 
unreasonable shall be considered agency action for purposes of judicial 
5 use 701. review under chapter 7 of title 5, United States Code. This subsection 

shall not take effect until two years after the effective date of this Act. 

(g) Petition for Standards for the Development of Test Data. — 
A person intending to manufacture or process a chemical substance 

In/ra. for which notice is required under section 5(a) and who is not required 

under a rule under subsection (a) to conduct tests and submit data 
on such substance may petition the Administrator to prescribe stand- 
ards for the development of test data for sucli substance. The Admin- 
istrator shall by order either grant or deny any such petition within 
60 days of its receipt. If the petition is granted, the Administrator 
shall prescribe such standards for sucli substance within 75 days of 
Publication in the date the petition is granted. If the petition is denied, the Admin- 
Federal Register, istrator shall publish, subjex't to section 14, in the Federal Register the 
Post, p. 2034. reasons for such denial. 

SEC. 5. MANUFACTURING AND PROCESSING NOTICES. 
15 use 2604. (a) In General. — (1) Except as provided in subsection (h), no 

person may — 

(A) manufacture a new chemical substance on or after the 30th 
day aft^r the date on which the Administrator first publishes the 
list required by section 8 ( b ) , or 

(B) manufacture or process any chemical substance for a use 
which the Administrator has determined, in accordance with 
paragraph (2) , is a significant new use, 

unless such person submits to the Administrator, at least 90 days before 
such manufacture or processing, a notice, in accordance with subsection 
(d), of such person's intention to manufacture or process such sub- 
stance and such person complies with any applicable requirement of 
subsection (b). 



13 



PUBLIC LAW 94-469— OCT. 11, 1976 90 STAT. 2013 

(2) A determination by the Administrator that a use of a chemical 
substance is a significant new use with respect to which notification 
is required under paragraph (1) shall be made by a rule promulgated 
after a consideration of all relevant factors, including — 

(A) the projected volume of manufacturing and processing of 
a chemical substance, 

(B) the extent to which a use changes the type or form of 
exposure of human beings or the environment to a chemical 
substance, 

(C) the extent to which a use increases the magnitude and 
duration of exposure of human beings or the environment to a 
chemical substance, and 

(D) the reasonably anticipated manner and methods of manu- 
facturing, processing, distribution in commerce, and disposal of 
a chemical substance. 

(b) Submission of Test Data. — (1) (A) If (i) a person is required 
by subsection (a) (1) to submit a notice to the Administrator before 
beginning the manufacture or processing of a chemical substance, 
and (ii) such person is required to submit test data for such sub- 
stance pursuant to a rule promulgated under section 4 before the 
submission of such notice, such person shall submit to the Adminis- 
trator such data in accordance with such rule at the time notice is 
submitted in accordance with subsection (a) (1). 

<B) If- . . 

(i) a person is required by subsection (a)(1) to submit a 
notice to the Administrator, and 

(ii) such person has been granted an exemption under section 
4(c) from tne requirements of a rule promulgated under section 
4 before the submission of such notice, 

such person may not, before the expiration of the 90 day period which 
begins on the date of the submission in accordance with such rule of 
the test data the submission or development of which was the basis 
for the exemption, manufacture such substance if such person is 
subject to subsection (a)(1)(A) or manufacture or process such 
substance for a significant new use if the person is subject to subsection 
(a)(1)(B). 
(2) (A) If a person — 

(i) is required by subsection (a) (1) to submit a notice to the 
Administrator before beginning the manufacture or processing 
of a chemical substance listed under paragraph (4), and 

(ii) is not required by a rule promulgated under section 4 
before the submission of such notice to submit test data for such 
substance, 

such person shall submit to the Administrator data prescribed by 
subparagraph (B) at the time notice is submitted in accordance with 
subsection (a)(1). 

(B) Data submitted pursuant to subparagraph (A) shall be data 
which the person submitting the data believes show that — 

(i) in the case of a substance with respect to which notice is 
required under subsection (a) (1) (A), the manufacture, process- 
ing, distribution in commerce, use, and disposal of the chemical 
suDstance or any combination of such activities will not present 
an unreasonable risk of injury to health or the environment, or 

(ii) in the case of a chemical substance with respect to which 
notice is required under subsection (a)(1)(B), the intended 
significant new use of the chemical substance will not present an 
unreasonable risk of injury to health or the environment. 



14 



90 STAT. 2014 



PUBLIC LAW 94^9--OCT. 11, 1976 



Post, p. 2034. 



Oral 

presentation. 

Transcript. 

Publication. 



Publication in 
Federal Register. 



(3) Data submitted under paragraph (1) or (2) shall be made 
available, subject to section 14, for examination by interested persons. 

(4) (A) (i) The Administrator may, by rule, compile and keep 
current a list of chemical substances with respect to which the 
Administrator finds that the manufacture, processing, distribution in 
commerce, use, or disposal, or any combination of such activities, 
presents or may present an unreasonable risk of injury to health or 
the environment. 

(ii) In making a finding under clause (i) that the manufacture, 
processing, distribution in commerce, use, or disposal of a chemical 
substance or any combination of such activities presents or may present 



Administrator shall consider all relevant factors, including — 

(I) the effects of the chemical substance on health and the 
magnitude of human exposure to such substance; and 

(II) the effects of the chemical substance on the environment 
and the magnitude of environmental exposure to such substance. 

(B) The Administrator shall, in prescribing a rule under subpara- 
graph (A) which lists any chemical substance, identify those uses, 
if any, which the Administrator determines, by rule under subsection 
(a) (2), would constitute a significant new use of such substance. 

(C) Any rule imder subparagraph (A), and any substantive 
amendment or repeal of such a rule, shall be promulgated pursuant 
to the procedures specified in section 553 of title 5, L^nited States 
Code, except that {i) the Administrator shall give interested persons 
an opportunity for tne oral presentation of data, views, or arguments, 
in addition to an opportunity to make written submissions, (ii) a 
transcript shall be kept of any oral presentation, and (iii) the Admin- 
istrator shall make and publish with the rule the finding described 
in subparagraph (A). 

(c) Extension of Xotice Period. — The Administrator may for 
good cause extend for additional periods (not to exceed in the aggre- 
gate 90 days) the period, prescribed by subsection (a) or (b) before 
which the manufacturing or processing of a chemical substance sub- 
ject to such subsection may begin. Subject to section 14, such an 
extension and the reasons tnerefor shall be published in the Federal 
Register and shall constitute a final agency action subject to judicial 
review. 

(d) Content of Notice ; Publications in the Federal Register. — 
(1) The notice required by subsection (a) shall include — 

(A) insofar as known to the person submitting the notice or 
insofar as reasonably ascertainable, the information described in 
subparagraphs (A), (B), (C), (D), (F), and (G) of section 
8(a) (2), and 

(IB) in such form and manner as the Administrator may pre- 
scribe, any test data in the possession or control of the person 
giving such notice which are related to the effect of any manu- 
facture, processing, distribution in commerce, use, or disposal of 
such substance or any article containing such substance, or of any 
combination of such activities, on health or the environment, and 
(C) a description of any other data concerning the environ- 
mental and health effects of such substance, insofar as known to 
the person making the notice or insofar as reasonably ascertain- 



Such a notice shall be made available, subject to section 14. for exam- 
ination by interested persons. 

(2) Subject to section 14, not later than five days (excluding Satur- 
days, Sundays and legal holidays) after the date of the receipt of a 




able. 



15 



PUBUC LAW 94^9--OCT. 11, 1976 90 STAT. 2015 

notice under subsection (a) or of data under subsection (b), the 
Administrator shall publish in the Federal Register a notice which — 

(A) identifies the chemical substance for which notice or data 
has been received ; 

(B) lists the uses or intended uses of such substance; and 

(C) in the case of the receipt of data under subsection (b), 
describes the nature of the tests performed on such substance and 
any data which was developed pursuant to subsection (b) or a 
rule under section 4. 

A notice under this paragraph respecting a chemical substance shall 
identify the chemical substance by generic class unless the Administra- 
tor determines that more specific identification is required in the 
public interest. 

(3) At the beginning of each month the Administrator shall pub- 
lish a list in the Federal Register of (A) each chemical substance for 
which notice has been received under subsection (a) and for which 
the notification period prescribed by subsection (a) , (b) , or (c) has not 
expired, and (B) each chemical substance for which such notifica- 
tion period has expired since the last publication in the Federal Regis- 
ter of such list. 

(e) Regulation Pending Development of Information. — (1) (A) 
If the Administrator determines that — 

(i) the information available to the Administrator is insuf- 
ficient to permit a reasoned evaluation of the health and environ- 
mental effects of a chemical substance with respect to which notice 
is required by subsection (a) ; and 

(ii) (I) in the absence of sufficient information to permit the 
Administrator to make such an evaluation, the manufacture, 
processing, distribution in commerce, use, or disposal of such 
substance, or any combination of such activities, may present an 
imreasonable risk of injury to health or the environment, or 

(II) such substance is or will be produced in substantial quan- 
tities, and such substance either enters or may reasonably be 
anticipated to enter the environment in substantial quantities or 
there is or may be significant or substantial human exposure to the 
substance, 

the Administrator may issue a proposed order, to take effect on the Proposed order, 
expiration of the notification period applicable to the manufactunng 
or processing of such substance under subsection (a), (b), or (c), to 
prohibit or limit the manufacture, processing, distribution in com- 
merce, use, or disposal of such substance or to prohibit or limit any 
combination of such activities. 

(B) A proposed order may not be issued under subparagraph (A) 
respecting a chemical substance (i) later than 45 days before the 
expiration of the notification period applicable to the manufacture or 
processing of such substance under subsection (a), (b), or (c), and 
(ii) unless the Administrator has, on or before the issuance of the 
proposed order, notified, in writing, each manufacturer or processor, 
as the case may be, of such substance of the determination which 
underlies such order. 

(C) If a manufacturer or processor of a chemical substance to be 
subject to a proposed order issued under subparagraph (A) files with 
the Administrator (within the 30-day period beginning on the date 
such manufacturer or processor received the notice required by subpar- 
agraph (B) (ii)) objections specifying with particularity the provi- 
sions of the order deemed objectionable and stating the grounds 
therefor, the proposed order shall not take effect. 



16 



90 STAT. 2016 PUBLIC LAW 94-469— OCT. 11, 1976 

Injunction, (2) (A) (i) Except as provided in clause (ii), if with respect to a 

application. chemical substance with respect to which notice is required by subsec- 

tion (a), the Administrator makes the determination described in 
paragraph (1) (A) and if — 

(I) the Administrator does not issue a proposed order under 
paragraph (1) respecting such substance, or 

(II) the Administrator issues such an order respecting such 
substance but such order does not take effect because objections 
were filed under paragraph (1) (C) with respect to it, 

the Administrator, through attorneys of the Environmental Protection 
Agency, shall apply to the United States District Court for the Dis- 
trict of Columbia or the United States district court for the judicial 
district in which the manufacturer or processor, as the case may be, of 
such substance is found, resides, or transacts business for an injunction 
to prohibit or limit the manufacture, processing, distribution in com- 
merce, use, or disposal of such substance (or to prohibit or limit any 
combination of such activities) . 

(ii) If the Administrator issues a proposed order under paragraph 
(1) (A) respecting a chemical substance but such order does not take 
effect because objections have been filed under paragraph (1) (C) with 
respect to it, the Administrator is not required to apply for an injunc- 
tion under clause (i) respecting such substance if the Administrator 
determines, on the basis of such objections, that the determinations 
under paragraph ( 1 ) ( A) may not be made. 

(B) A district court of the United States which receives an appli- 
cation under subparagraph (A) (i) for an injunction respecting a 
chemical substance shall issue such injunction if the court finds that — 

(i) the information available to the Administrator is insufficient 
to permit a reasoned evaluation of the health and environmental 
effects of a chemical substance with respect to which notice is 
required by subsection (a) ; and 

(ii) (I) in the absence of sufficient information to permit the 
Administrator to make such an evaluation, the manufacture, proc- 
essing, distribution in commerce, use, or disposal of such 
substance, or any combination of such activities, may present an 
unreasonable risk of injury to health or the environment, or 

(II) such substance is or will be produced in substantial quan- 
tities, and such substance either enters or may reasonably be 
anticipated to enter the environment in substantial quantities or 
there is or may be significant or substantial human exposure to 
the substance. 

(C) Pending the completion of a proceeding for the issuance of an 
injunction under subparagraph (B) respecting a chemical substance, 
the court may, upon application of the Administrator made through 
attorneys of the Environmental Protection Agency, issue a temporary 
restraining order or a preliminary injunction to prohibit the manu- 
facture, processing, distribution in commerce, use, or disposal of such 
a substance (or any combination of such activities) if the court finds 
that the notification period applicable under subsection (a), (b), or 
(c) to the manufacturing or processing of such substance may expire 
before such proceeding can be completed. 

(D) After the submission to the Administrator of test data sufficient 
to evaluate the health and environmental effects of a chemical sub- 
stance subject to an injunction issued under subparagraph (B) and 
the evaluation of such data by the Administrator, the district court 
of the United States which issued such injunction shall, upon petition, 
dissolve the injunction unless the Administrator has initiated a pro- 



17 



PUBUC LAW 94-469— OCT. 11, 1976 



90 STAT. 2017 



ceeding for the issuance of a rule under section 6(a) respecting the 
substance. If such a proceeding has been initiated, such court shall con- 
tinue the injunction in effect until the effective date of the rule pro- 
mulgated in such proceeding or, if such proceeding is terminated 
without the promulgation of a rule, upon the termination of the pro- 
ceeding, whichever occurs first. 

(f ) Protection Against Unreasonable Risks. — (1) If the Admin- 
istrator finds that there is a reasonable basis to conclude that the manu- 
facture, processing, distribution in commerce, use, or disposal of a 
chemical substance with respect to which notice is required by subsec- 
tion (a), or that any combination of such activities, presents or wiU 
present an unreasonable risk of injury to health or environment before 
a rule promulgated under section 6 can protect against such risk, the 
Administrator shall, before the expiration of the notification period 
applicable under subsection (a), (b), or (c) to the manufacturing or 
processing of such substance, take the action authorized by paragraph 
(2) or (3) to the extent necessary to protect against such risk. 

(2) The Administrator may issue a proposed rule under section Proposed rule 
6(a) to apply to a chemical substance with respect to which a finding 

was made under paragraph (1) — 

(A) a i-equirement limiting the amount of such substance 
which may be manufactured, processed, or distributed in 
commerce, 

(B) a requirement described in paragraph (2), (3), (4), (5), 
(6), or (7) of section 6(a), or 

(C) any combination of the requirements referred to in sub- 
paragraph (B). 

Such a proposed rule shall be effective upon its publication in the Fed- 
ei-al Register. Section 6(d)(2)(B) shall apply with respect to such 
rule. 

(3) (A) The Administrator may — 

(i) issue a proposed order to prohibit the manufacture, process- 
ing, or distrioution in commerce of a substance with respect to 
which a finding was made under paragraph (1), or 

(ii) apply, through attorneys of the Environmental Protection 
Agency, to the United States District Court for the District of 
Columbia or the United States district court for the judicial dis- 
trict in which the manufacturer, or processor, as the case may be, 
of such substance, is found, resides, or transacts business for an 
injunction to prohibit the manufacture, processing, or distribu- 
tion in commerce of such substance. 

A proposed order issued under clause (i) respecting a chemical 
substance shall take effect on the expiration of the notification period 
applicable under subsection (a), (b), or (c) to the manufacture or 
processing of such substance. 

(B) If the district court of the United States to which an applica- 
tion has been made under subparagraph (A) (ii) finds that there is a 
reasonable basis to conclude that the manufacture, processing, 
distribution in commerce, use, or disposal of the chemical substance 
with respect to which such application was made, or that any combina- 
tion of such activities, presents or will present an unreasonable risk 
of injury to health or the environment before a rule promulgated 
under section 6 can protect against such risk, the court shall issue 
an injunction to prohibit the manufacture, processing, or distribution 
in commerce of such substance or to prohibit any combination of such 
activities. 



Publication in 
Federal Register. 



Proposed order. 



Injunction 
application. 



18 



90 STAT. 2018 PUBLIC LAW 94^9— OCT. 11, 1976 

(C) The provisions of subparagraphs (B) and (C) of subsection 
(e) (1) shall apply with respect to an order issued under clause (i) 
of subparagraph (A) ; and the provisions of subparagraph (C) of sub- 
section (e) (2) shall apply with respect to an injunction issued under 
subparagraph (B). 

(D) If the Administrator issues an order pursuant to subparagraph 
(A) (i) respecting a chemical substance and objections are filed in 
accordance with subsection (e) (1) (C), the Administrator shall seek 
an injunction under subparagraph (A) (ii) respecting such substance 
unless the Administrator determines, on the basis of such objections, 
that such substance does not or will not present an unreasonable risk 
of injury to health or the environment. 

(g) Statement of Reasons for Not Taking Action. — If the 
Adininistrator has not initiated any action under this section or section 
6 or 7 to prohibit or limit the manufacture, processing, distribution 
in commeice, use, or disposal of a chemical substance, with respect to 
which notification or data is required by subsection (a) (1) (B) or (b), 
before the expiration of the notification period applicable to the manu- 
facturing or processing of such substance, the Administrator shall 
publish a statement of the Administrator's reasons for not initiating 

Publication in such action. Such a statement shall be published in the Federal Reg- 
Federal Register, ister before the expiration of such period. Publication of such state- 
ment in accordance with the preceding sentence is not a prerequisite 
to the manufacturing or processing of the substance with respect to 
which the statement is to be published. 

(h) Exemptions. — (1) The Administrator may, upon application, 
exempt any person from any requirement of subsection (a) or (b) to 
permit such person to manufacture or process a chemical^ substance 
for test marketing purposes — 

(A) upon a showing by such person satisfactory' to the Admin- 
istrator that the manufacture, processing, distribution in 
commerce, use, and disposal of such substance, and that any com- 
bination of such activities, for such purposes will not present any 
unreasonable risk of injury- to health or the environment, and 

(B) under such restrictions as the Administrator considers 
appropriate. 

(2) (A) The Administrator may, upon application, exempt any per- 
son from the requirement of subsection (b) (2) to submit data for a 
chemical substance. If, upon receipt of an application under the pre- 
ceding sentence, the Administrator determines that — 

(i) the chemical substance with respect to which such applica- 
tion was submitted is equivalent to a chemical substance for which 
data has been submitted to the Administrator as required by sub- 
section (b) (2), and 

(ii) submission of data by the applicant on such substance 
would be duplicative of data which has been submitted to the 
Administrator in accordance with such subsection, 

the Administrator shall exempt the applicant from tlie requirement 
to submit such data on such substance. No exemption which is granted 
under this subparagraph with respect to the submission of data for a 
chemical substance may take effect before the beginning of the reim- 
bursement period applicable to such data. 
Fair and (B) If the Administrator exempts any person, under subpara<rraph 

equitable (A), from Submitting data required under subsection fb) (2) for a 

reimbursement. chemical substance because of the existence of previously submitted 
data and if such exemption is granted during the reimbursement period 
for such data, then (unless such person and the persons referred to in 



19 



PUBLIC LAW 94-469— OCT. 11, 1976 90 STAT. 2019 

clauses (i) and (ii) agree on the amount and method of reimbui-se- 
ment) the Administrator shall order the person granted the exemption 
to provide fair and equitable reimbursement (in an amount determined 
under rules of the Administrator) — 

(i) to the person who previously submitted the data on which 
the exemption was based, for a portion of the costs incurred by 
such person in complying with the requirement under subsection 
(b) (2) to submit such data, and 

(ii) to any other person who has been required under this sub- 
paragraph to contribute with respect to such costs, for a portion 
of the amount such person was required to contribute. 

In promulgating rules for the determination of fair and equitable 
reimbursement to the persons described in clauses (i) and (ii) for 
costs incurred with respect to a chemical substance, the Administrator 
shall, after consultation with the Attorney General and the Federal 
Trade Commission, consider all relevant factors, including the effect 
on the competitive position of the person required to provide reim- 
bursement in relation to the persons to be reimbursed and the share of 
the market for such substance of the person required to provide reim- 
bursement in relation to the share of such market of the persons to be 
reimbursed. For purposes of judicial review, an order under this 
subparagraph shall be considered final agency action. 

(C) For purposes of this paragraph, the reimbursement period for Reimbursement 
any previously submitted data for a chemical substance is a period — period. 

(i) beginning on the date of the termination of the prohibition, 
imposed under this section, on the manufacture or processing of 
such substance by the person who submitted such data to the 
Administrator, and 

(ii) ending — 

(I) five years after the date referred to in clause (i), or 

(II) at the expiration of a period which begins on the 
date referred to in clause (i) and is equal to the period which 
the Administrator determines was necessary to develop such 
data, 

whichever is later. 

(3) The requirements of subsections (a) and (b) do not apply with 
respect to the manufacturing or processing of any chemical sub- 
stance which is manufactured or processed, or proposed to be manu- 
factured or processed, only in small quantities (as defined by the 
Administrator by rule) solely for purposes of — 

(A) scientific experimentation or analysis, or 

(B) chemical research on, or analysis of such substance or 
another substance, including such research or analysis for the 
development of a product, 

if all persons engaged in such experimentation, research, or analysis 
for a manufacturer or processor are notified (in such form and manner 
as the Administrator may prescribe) of any risk to health which the 
manufacturer, processor, or the Administrator has reason to believe 
may be associated with such chemical substance. 

(4) The Administrator may, upon application and by rule, exempt 
the manufacturer of any new chemical substance from all or part of 
the requirements of this section if the Administrator determines that 
the manufacture, processing, distribution in commerce, use, or dis- 
posal of such chemical substance, or that any combination of such 
activities, will not present an unreasonable risk of injury to health or 
the environment. A rule promulgated under this paragraph (and any 
substantive amendment to, or repeal of, such a rule) shall be promul- 
gated in accordance with paragraphs (2) and (3) of section 6(c). 



89-139 (360) O - 76 - - 8 



20 



90 STAT. 2020 



PUBLIC LAW 94-469— OCT. 11, 1976 



Publication in 
Federal Register. 
Comments. 



Publication in 
Federal Register. 



15 use 2605. 



(5) The Administrator may, upon application, make the require- 
ments of subsections (a) and (b) inapplicable with respect to the 
manufacturing or processing of any chemical substance (A) which 
exists temporarily as a result of a chemical reaction in the manufac- 
turing or processing of a mixture or another chemical substance, and 
(B) to which there is no, and will not be, human or environmental 
exposure. 

(6) Immediately upon receipt of an application under paragraph 
(1) or (5) the Administrator shall publish in the Federal Register 
notice of the receipt of such application. The Administrator shall give 
interested persons an opportunity to comment upon any such applica- 
tion and shall, within 45 days of its receipt, either approve or deny the 
application. The Administrator shall publish in the Federal Register 
notice of the approval or denial of such an application. 

(i) Definition. — For purposes of this section, the terms "manufac- 
ture" and "process" mean manufacturing or processing for commercial 
purj)Oses. 

SEC. 6. REGULATION OF HAZARDOUS CHEMICAL SUBSTANCES AND 
MIXTURES. 

(a) Scope of Regulation. — If the Administrator finds that there is 
a reasonable basis to conclude that the manufacture, processing, dis- 
tribution in connnerce, use, or disposal of a chemical substance or 
mixture, or that any combination of such activities, presents or will 
present an unreasonable risk of injury to health or the environment, 
the Administrator shall by rule apply one or more of the following 
requirements to such substance or mixture to the extent necessary to 
protect adequately against such risk using the least burdensome 
requirements : 

(1) A rc(<[uirement (A) prohibiting the manufacturing, process- 
ing, or distribution in connnerce of such substance or mixture, or 
(B) limiting the amount of such substance or mixture which may 
be manufactured, processed, or distributed in commerce. 

(2) A requirement — 

(A) prohibiting the manufacture, processing, or distribu- 
tion in commerce of such substance or mixture for (i) a 
particular use or (ii) a particular use in a concentration in 
excess of a level specified by the Administrator in the rule 
imposing the requirement, or 

(B) limiting the amount of such substance or mixture 
which may be manufactured, processed, or distributed in 
commerce for (i) a particular use or (ii) a particular use 
in a concentration in excess of a level specified by the 
Administrator in the rule imposing the requirement. 

(3) A requirement that such substance or mixture or any 
article containing such substance or mixture be marked with or 
accompanied by clear and adequate warnings and instructions 
with respect to its use, distribution in commerce, or disposal or 
with i-espect to any combination of such activities. The form and 
content of such warnings and instructions shall be prescribed by 
the Administrator. 

(4) A requirement that manufacturers and processors of such 
substance or mixture make and retain records of the processes 
used to manufacture or process such substance or mixture and 
monitor or conduct tests which are reasonable and necessary to 
assure compliance with the requirements of any rule applicable 
under this subsection. 



21 



PUBLIC LAW 94^9— OCT. 11, 1976 90 STAT. 2021 

(5) A requirement prohibiting or otherwise regulating any 
manner or method of commercial use of such substance or 
mixture. 

(6) (A) A requirement prohibiting or otherwise regulating any 
manner or method of disposal of such substance or mixture, or 
of any article containing such substance or mixture, by its manu- 
facturer or processor or by any other person who uses, or disposes 
of, it for commercial purposes. 

(B) A requirement under subparagraph (A) may not require 
any person to take any action which would be in violation of 
any law or requirement of, or in effect for, a State or political 
subdivision, and shall require each person subject to it to notify 
each State and political subdivision in which a required disposal 
may occur of such disposal. 

(7) A requirement directing manufacturers or processors of 
such substance or mixture (A) to give notice of such unreasonable 
risk of injury to distributors in commerce of such substance or 
mixture and, to the extent reasonably ascertainable, to other per- 
sons in possession of such substance or mixture or exposed to such 
substance or mixture, (B) to give public notice of such risk of 
injury, and (C) to replace or repurchase such substance or 
mixture as elected by the person to which the requirement is 
directed. 

Any requirement (or combination of requirements) imposed under 
this subsection may be limited in application to specified geographic 
areas. 

(b) Quality Control. — If the Administrator has a reasonable 
basis to conclude that a particular manufacturer or processor is manu- 
facturing or processing a chemical substance or mixture in a manner 
which unintentionally causes the chemical substance or mixture to 
present or which will cause it to present an unreasonable risk of 
injury to health or the environment — 

(1) the Administrator may by order require such manufac- 
turer or processor to submit a description of the relevant quality 
control procedures followed in the manufacturing or processing 
of such chemical substance or mixture ; and 

(2) if the Administrator determines — 

(A) that such quality control procedures are inadequate 
to prevent the chemical substance or mixture from presenting 
such risk of injury, the Administrator may order the manu- 
facturer or processor to revise such quality control procedures 
to the extent necessary to remedy such inadequacy ; or 

(B) that the use of such quality control procedures has 
resulted in the distribution in commerce of chemical substances 
or mixtures which present an unreasonable risk of injury to 
health or the environment, the Administrator may order the 
manufacturer or processor to (i) give notice of such risk to 
processors or distributors in commerce of any such sub- 
stance or mixture, or to both, and, to the extent reasonably 
ascertainable, to any other person in possession of or exposed 
to any such substance, (ii) to give public notice of such risk, 
and (iii) to provide such replacement or repurchase of any 
such substance or mixture as is necessary to adequately pro- 
tect health or the environment. 

A detennination under subparagraph (A) or (B) of paragraph (2) Hearing, 
shall be made on the record after opportunity for hearing in accord- 
ance with section 654 of title 5, United States Code. Any manufacturer 



22 



90 STAT. 2022 



PUBLIC LAW 94-469— OCT. 11, 1976 



Statement, 
publication. 



5 use 556, 557. 
Notice, 
publication. 
Written data, 
views, arguments, 
submittal. 
Hearing. 
Final rule. 

Informal 
heariogs. 



or processor subject to a requirement to replace or repurchase a chem- 
ical substance or mixture may elect either to replace or repurchase 
the substance or mixture and shall take either such action in the man- 
ner prescribed by the Administrator. 

(c) Promulgation of Subsection (a) Rules. — (1) In promulgat- 
ing any rule under subsection (a) with respect to a chemical substance 
or mixture, the Administrator shall consider and publish a statement 
with respect to — 

(A) the effects of such substance or mixture on health and the 
magnitude of the exposure of human beings to such substance or 
mixture. 

( B ) the etfects of such substance or mixture on the environment 
and the magnitude of the exposure of the environment to such 
substance or mixture, 

(C) the benefits of such substance or mixture for various uses 
and the availability of substitutes for such uses, and 

(D) the reasonably ascertainable economic consequences of the 
rule, after consideration of the effect on the national economy, 
small business, technological iimovation, the enviromnent, and 
public health. 

If the Administrator determines that a risk of injury to health or the 
environment could be eliminated or reduced to a sufficient extent by 
actions taken under another Federal law (or laws) administered in 
whole or in part by the Administrator, the Administrator may not 
promulgate a rule under subsection (a) to protect against such risk 
of injury unless the Administrator finds, in the Administrators dis- 
cretion, that it is in the public interest to protect against such risk 
under this Act. In making such a finding the Administrator.shall con- 
sider (i) all relevant aspects of the risk, as determined by the Adminis- 
trator in the Administrators discretion, (ii) a comparison of the 
estimated costs of complying with actions taken under this Act and 
under such law (or laws), and (iii) the relative efficiency of actions 
under this Act and under such law (or laws) to protect against such 
risk of injury. 

(2) When prescribing a rule under subsection (a) the Adminis- 
trator shall proceed in accordance with section 553 of title 5, United 
States Code (without regard to any reference in such section to sec- 
tions 556 and 557 of such title), and shall also (A) publish a notice of 
proposed rulemaking stating with particularity the reason for the 
proposed rule: (B) allow interested persons to submit written data, 
views, and arguments, and make all such submissions publicly avail- 
able; (C) provide an oppoitunity for an informal hearing in accord- 
ance with paragraph (H) ; (D) promulgate, if appropriate, a final 
rule based on the matter in the rulemaking record (as defined in section 
19(a) ), and (E) make and publish with the rule the finding described 
in subsection (a). 

(3) Informal hearings required by paragraph (2) (C) shall be con- 
ducted by the Administrator in acx:ordance with the following 
requirements : 

(A) Subject to subparagraph (B), an interested [)erson is 
entitled — 

(i) to present such person's position orally or by docu- 
mentary submissions (or both), and 

(ii) if the Administrator determines that there are dis- 
puted issues of material fact it is nex'CvSsary to resolve, to 
present such rebuttal submissions and to conduct (or have 
conducted under subparagraph (B) (ii) ) such cross-examina- 



23 



PUBLIC LAW 94-469— OCT. 11, 1976 90 STAT. 2023 

tion of persons as the Administrator determines (I) to be 
appropriate, and (II) to be required for a full and true dis- 
closure with respect to such issues. 

(B) The Administrator may prescribe such rules and make such Rules, 
rulings concerning procedures m such hearings to avoid unneces- 
sary costs or delay. Such rules or rulings may include (i) the 
imposition of reasonable time limits on each interested person's 

oral presentations, and (ii) requirements that any cross-examina- 
tion to which a person may be entitled under subparagraph (A) 
be conducted by the Administrator on behalf of that person in such 
manner as the Administrator determines (I) to be appropriate, 
and (II) to be required for a full and true disclosure with respect 
to disputed issues of material fact. 

(C) (i) Except as provided in clause (ii), if a group of persons 
each of whom under subparagraphs (A) and (B) would be 
entitled to conduct (or have conducted) cross-examination and 
who are determined by the Administrator to have the same or 
similar interests in the proceeding cannot agree upon a single 
representative of such interests for purposes of cross-examination, 
the Administrator may make rules and rulings (I) limiting the 
representation of such interest for such purposes, and (II) gov- 
erning the manner in which such cross-examination shall be 
limited. 

(ii) "V^Hicn any person who is a member of a group with respect 
to which the Administrator has made a determination under 
clause (i) is unable to agree upon group representation with the 
other membei-s of the group, then such pei-son shall not be denied 
under the authority of clause (i) the opportunity to conduct (or 
have conducted) cross-examination as to issues affecting the per- 
son's particular interests if (I) the person satisfies the Admin- 
istrator that the person has made a reasonable and good faith 
effort to reach agi-eement upon group representation with tlie 
other members of the group and (II) the Administrator deter- 
mines that there are substantial and relevant issues which are not 
adequately presented by the gioup representative. 

(D) A verbatim transcript shall be taken of any oral presen- Verbatim 
tation made, and cross-examination conducted in any informal transcript, 
hearing under this subsection. Such transcript shall be available 

to the public. 

(4) (A) The Administrator may, pursuant to rules prescribed by the Compensation. 
Administrator, provide compensation for reasonable attorneys' fees, 
expert witness fees, and other costs of participating in a rulemaking 
proceeding for the promulgation of a rule under subsection (a) to 
any person — 

(i) who represents an interest which would substantially con- 
tribute to a fair determination of the issues to be resolved in the 
proceeding, and 

(ii) if- 

(I) the economic interest of such pei-son is small in com- 
parison to the costs of effective participation in the proceed- 
ing by such person, or 

(II) such person demonstrates to the satisfaction of the 
Administrator that such person does not have sufficient 
resources adequately to participate in the proceeding without 
compensation under this subparagraph. 

In determining for purposes of clause (i) if an interest will substan- 
tially contribute to a fair determination of the issues to be resolved in 



24 



90 STAT. 2024 PUBLIC LAW 94-469— OCT. 11, 1976 

a proceeding, the Administrator shall take into account the number 
and complexity of such issues and the extent to which representation 
of such interest will contribute to widespread public participation in 
the proceeding and representation of a fair balance of interests for 
the resolution of such issues. 

(B) In determining whether compensation should be provided to 
a person under subparagraph (A) and the amount of such compensa- 
tion, the Administrator shall take into account the financial burden 
which will be incurred by such person in participating in the rule- 
making proceeding. The Administrator shall take such action as 
may be necessary to ensure that the aggregate amount of compensa- 
tion paid under this paragraph in any fiscal year to all persons who, 
in rulemaking proceedings in which they receive compensation, ai"e 
persons who either — 

(i) would be regulated by the proposed rule, or 

(ii) represent persons who would be so regulated, 

may not exceed 25 per centum of the aggregate amount paid as com- 
pensation under this paragraph to all persons in such fiscal year. 

(5) Paragraph (1), (2), (3), and (4) of this subsection apply 
to the pronmlgation of a rule repealing, or making a substantive 
amendment to, a rule promulgated under subsection (a). 

(d) Effective Date. — (1) The Administrator shall specify in any 
rule under subsection (a) the date on which it shall take effect, which 
date shall be as soon as feasible. 
Publication in (2) (A) The Administrator may declare a proposed rule under sub- 

Federal Register, section (a) to be effective upon its publication in the Federal Register 
and until the effective date of final action taken, in accordance with 
subparagraph (B), respecting such rule if — 

(i) the Administrator determines that — 

(I) the manufacture, processing, distribution in com- 
merce, use, or disposal of the chemical substance or mixture 
subject to such proposed rule or any combination of such 
activities is likely to result in an unreasonable risk of serious 
or widespread injury to health or the environment before 
such effective date; and 

(II) making such proposed rule so effective is necessary to 
protect the public interest ; and 

(ii) in the case of a proposed rule to prohibit the manufacture, 
processing, or distribution of a chemical substance or mixture 
because of the risk determined under clause (i) (I), a court has 
in an action under section 7 granted relief with respect to such 
risk associated with such substance or mixture. 

Such a proposed rule which is made so effective shall not, for pur- 
poses of judicial review, be considered final agency action. 
Notice. (B) If the Administrator makes a proposed rule effective upon its 

publication in the Federal Register, the Administrator shall, as expe- 
ditiously as possible, give interested persons prompt notice of such 
action, j)rovide reasonable opportunity, in accordance with paragraphs 
(2) and (3) of subsection (c), for a hearing on such rule, and either 
promulgate such rule (as proposed or with modifications) or revoke 
it; and if such a hearing is requested, the Administrator shall com- 
mence the hearing within five days from the date such request is made 
unless the Administrator and the person making the request agree 
upon a later date for the hearing to begin, and after the hearing is 
concluded the Administrator shall, within ten days of the conclusion 
of the hearing, either promulgate such rule (as proposed or with 
modifications) or revoke it. 



25 



PUBLIC LAW 94-469— OCT. 11, 1976 



90 STAT. 2025 



(e) PoLYCHLORiNATED BiPiLENYLS. — (1) Within six months after 
the effective date of this Act the Administrator shall promulgate 
rules to — 

(A) prescribe methods for the disposal of poly chlorinated 
biphenyls, and 

(B) require polychlorinated biphenyls to be marked with clear 
and adequate warnings, and instructions with respect to their 
processing, distribution in commerce, use, or disposal or with 
respect to any combination of such activities. 

Requirements prescribed by rules under this paragraph shall be con- 
sistent with the requirements of paragraphs (2) and (3). 

(2) (A) Except as provided under subparagraph (B), effective one 
year after the effective date of this Act no person may manufacture, 
l)rocess, or distribute in commerce or use any polychlorinated biphenyl 
in any manner other than in a totally enclosed manner. 

(B) The Administrator may by rule authorize the manufacture, 
processing, distribution in commerce or use (or any combination of 
such activities) of any polychlorinated biphenyl in a maimer other than 
in a totally enclosed manner if the Administrator finds that such manu- 
facture, processing, distribution in commerce, or use (or combination 
of such activities) will not present an unreasonable risk of injury to 
health or the environment. 

(C) For the purposes of this paragraph, the term "totally enclosed 
manner" means any manner which will ensure that any exposure of 
human beings or the environment to a polychlorinated biphenyl will 
be insignificant as determined by the Administrator by rule. 

(3) (A) P^xcept as provided in subparagraphs (B) and (C) — 

(i) no person may manufacture any polychlorinated biphenyl 
after two years after the effective date of this Act, and 

(ii) no person may process or distribute in commerce any poly- 
chlorinated biphenyl after two and one-half years after such date. 

(B) Any pei-son may petition the Administrator for an exemption 
from the requirements of subparagraph (A), and the Administrator 
may grant by rule such an exemption if the Administrator finds 
that— 

(i) an unreasonable risk of injury to health or environment 
would not result, and 

(ii) good faith efforts have been made to develop a chemical 
substance which does not present an unreasonable risk of injury 
to health or the environment and which may be substituted for 
such polychlorinated biphenyl. 

An exemption granted under this subparagraph shall be subject to 
such terms and conditions as the Administrator may prescribe and 
shall be in effect for such period (but not more than one year from 
the date it is granted) as the Administrator may prescribe. 

(C) Subparagraph (A) shall not apply to the distribution in com- 
merce of any polychlorinated biphenyl if such polychlorinated 
biphenyl was sold for purposes other than resale before two and one 
half years after the date of enactment of this Act. 

(4) Any rule under paragraph (1), (2)(B), or (3) (B) shall be 
promulgated in accordance with paragraphs (2), (3), and (4) of sub- 
section (c). 

(5) This subsection does not limit the authority of the Adminis- 
trator, under any other provision of this Act or any other Federal law, 
to take action respecting any polychlorinated biphenyl. 



Rules. 



"Totally enclosed 
manner." 



Petition for 
exemption. 



Terms and 
conditions. 



79-313 - 77 -3 



26 



90 STAT. 2026 PUBLIC LAW 94-469— OCT. 11, 1976 

SEC. 7. IMMINENT HAZARDS. 

Civil action. (a) AcTioxs AUTHORIZED AND REQUIRED. — (1) The Administrator 

15 use 2606. may commence a civil action in an appropriate district court of the 
L^nited States — 

(A) for seizure of an imminently hazardous chemical sub- 
stance or mixture or any article containing such a substance or 
mixture, 

(B) for relief (as authorized by subsection (b)) against any 
person who manufactuies, processes, distributes in commerce, or 
uses, or disposes of, an imminently hazardous chemical substance 
or mixture or any article containing such a substance or mix- 
ture, or 

( C ) for both such seizure and relief. 

A civil action may be commenced under this paragraph notwith- 
standing the existence of a rule under section 4, 5, or 6 or an order 
under section 5, and notwithstanding the pendency of any adminis- 
trative or judicial proceeding under any provision of this Act. 

(2) If the Administrator has not made a rule under section 6(a) 
immediately effective (as authorized by subsection 6(d) (2) (A) (i) ) 
with respect to an imminently hazardous chemical substance or mix- 
ture, the Administrator shall commence in a district court of the United 
States with respect to such substance or mixture or article containing 
such substance or mixture a civil action described in subparagraph 
( A ) , ( B ) , or ( C ) of paragraph ( 1 ) . 
Jurisdiction. (b) Relief Authorized. — (1) The district court of the United 

States in which an action under subsection (a) is brought shall have 
jurisdiction to grant such temporary or permanent relief as^may be 
necessary to protect health or the environment from the unreasonable 
risk associated with the chemical substance, mixture, or article involved 
in such action. 

(2) In the case of an action under subsection (a) brought against 
a pei-son who manufactures, processes, or distributes in commerce a 
chemical substance or mixture or an article containing a chemical sub- 
stance or mixture, the relief authorized by paragraph (1) may include 
the issuance of a mandatory order requiring (A) in the case of pur- 
chasers of such substance, mixture, or article known to the defendant, 
notification to such purchasers of the risk associated with it; (B) pub- 
lic notice of such risk; (C) recall; (D) the replacement or repurchase 
of such substance, mixture, or .article; or (E) any combination of the 
actions described in the preceding clauses. 

(3) In the case of an action under subsection (a) against a chemi- 
cal substance, mixture, or article, such substance, mixture, or article 
may be proceeded against by process of libel for its seizure and con- 
demnation. Proceedings in such an action shall conform as nearly as 
possible to proceedings in rem in admiralty. 

(c) Venue and Consolidation. — (1) (A) An action under subsec- 
tion (a) against a person who manufactures, processes, or distributes a 
chemical substance or mixture or an article containing a chemical sub- 
stance or mixture may be brought in the United States District Court 
for the District of Columbia or for any judicial district in which any 
of the defendants is found, resides, or transacts business ; and process 
in such an action may be served on a defendant in any other district 
in which such defendant resides or may be found. An action under sub- 
section (a) against a chemical substance, mixture, or article muy be 
brought in any United States district court within the jurisdiction of 
which the substance, mixture, or article is found. 

(B) In determining the judicial district in which an action may be 
brought under subsection (a) in instances in which such action may 



27 



PUBLIC LAW 94-469— OCT. 11, 1976 90 STAT. 2027 

be brought in more than one judicial district, the Administrator shall 
take into account the convenience of the parties. 

(C) Subpeonas requiring attendance of witnesses in an action 
brought under subsection (a) may be served in any judicial district. 

(2) Whenever proceedings under subsection (a) involving identi- 
cal chemical substances, mixtures, or articles are pending in courts in 
two or more judicial districts, they shall be consolidated for trial by 
order of any such court upon application reasonably made by any 
party in interest, upon notice to all parties in interest, 

(d) Action LTnder Section 6. — Where appropriate, concurrently 
with the filing of an action under subsection (a) or as soon thereafter 
as may be practicable, the Administrator shall initiate a proceeding 
for the ])romulgation of a rule under section 6(a). 

(e) Representation. — Notwithstanding any other provision of law, 
in any action under subsection (a), the Administrator may direct 
attorneys of the Environmental Protection Agency to appear and 
represent the Administrator in such an action. 

(f) Definition. — For the purposes of subsection (a), the term 
"imminently hazardous chemical substance or mixture" means a chemi- 
cal substance or mixture which presents an imminent and unreason- 
able risk of serious or widespread injury to health or the environment. 
Such a risk to health or the environment shall be considered imminent 
if it is shown that the manufacture, processing, distribution in com- 
merce, use, or disposal of the chemical substance or mixture, or that any 
combination of such activities, is likely to result in such injury to 
health or the environment before a final rule under section 6 can 
protect against such risk. 

SEC. 8. REPORTING AND RETENTION OF INFORMATION. 

(a) Reports. — (1) The Administrator shall promulgate rules Rules, 
under which— 15 USC 2607. 

(A) each person (other than a small manufacturer or proc- 
essor) who manufactures or processes or proposes to manufacture 
or process a chemical substance (other than a chemical substance 
described in subparagraph (B)(ii)) shall maintain such rec- 
ords, and shall submit to the Administrator such reports, as the 
Administrator may reasonably require, and 

(B) each person (other than a small manufacturer or proc- 
essor) who manufactures or processes or proposes to manufacture 
or process — 

(i) a mixture, or 

(ii) a chemical substance in small quantities (as defined 
by the Administrator by rule) solely for purposes of scientific 
experimentation or analysis or chemical research on, or 
analysis of, such substance or another substance, including 
any such research or analysis for the development of a 
product, 

shall maintain records and submit to the Administrator reports 
but only to the extent the Administrator determines the main- 
tenance of records or submission of reports, or both, is necessary 
for the effective enforcement of this Act. 
The Administrator may not require in a rule promulgated under this 
paragraph the maintenance of records or the submission of reports 
with respect to changes in the proportions of the components of a 
mixture unless the Administrator finds that the maintenance of such 
records or the submission of such reports, or both, is necessary for 
the effective enforcement of this Act. For purposes of the compilation 



28 



90 STAT. 2028 PUBLIC LAW 94-469— OCT. 11, 1976 

of the list of chemical substances required under subsection (b), the 
Administrator shall promulgate rules pursuant to this subsection not 
later than 180 days after the effective date of this Act. 

(2) The Administrator may require under paragraph (1) mainte- 
nance of records and reporting with respect to the following insofar 
as known to the person making the report or insofar as reasonably 
ascertainable: 

(A) The common or trade name, the chemical identity, and the 
molecular structure of each chemical substance or mixture for 
which such a report is required. 

(B) The categories or proposed categories of use of each such 
substance or mixture. 

(C) The total amount of each such substance and mixture 
manufactured or processed, reasonable estimates of the total 
amount to be manufactured or processed, the amount manufac- 
tured or processed for each of its categories of use, and reasonable 
estimates of the amount to be manufactured or processed for each 
of its categories of use or proposed categories of use. 

(D) A description of the byproducts resulting from the manu- 
facture, processing, use, or disposal of each such substance or 
mixture. 

(E) All existing data concerning the environmental and health 
effects of such substance or mixture. 

(F) The number of individuals exposed, and reasonable esti- 
mates of the number who will be exposed, to such substance or 
mixture in their places of employment and the duration of such 
exposure. 

(G) In the initial report under paragraph (1) on such Substance 
or mixture, the manner or method of its disposal, and in any 
subsequent report on such substance or mixture, any change in 
such manner or method. 

To the extent feasible, the Administrator shall not require under 
paragraph (1), any reporting which is unnecessary or duplicative. 

(3) (A) (i) The Administrator may by rule require a small manu- 
facturer or processor of a chemical substance to submit to the Admin- 
istrator such information respectin/^ the chemical substance as the 
Administrator may require for publication of the first list of chemi- 
cal substances required by subsection (b). 

(ii) The Administrator may by rule require a small manufacturer 
or processor of a chemical substance or mixture — 

(I) subject to a rule proposed or promulgated under section 4, 
5(b) (4) , or 6, or an order in effect under section 5(e), or 

(II) with respect to which relief has been granted pursuant to 
a civil action brought under section 5 or 7, 

to maintain such records on such substance or mixture, and to submit 
to the Administrator such reports on such substance or mixture, as 
the Administrator may reasonably require. A rule under this clause 
requiring reporting may require reporting with respect to the matters 
referred to in paragraph (2) . 
Standards. (B) The Administrator, after consultation with the Administrator 

of the Small Business Administration, shall by rule prescribe stand- 
ards for determining the manufacturers and processors which qualify 
as small manufacturers and processors for purposes of this paragraph 
and paragraph ( 1 ) . 

(b) Inventory. — (1) The Administrator shall compile, keep cur- 
rent, and publish a list of each chemical substance which is manufac- 
tured or processed in the United States. Such list shall at least include 
each chemical substance which any person reports, imder section 5 or 



29 



PUBLIC LAW 94-469— OCT. 11, 1976 90 STAT. 2029 

subsection (a) of this section, is manufactured or processed in the 
United States. Such list may not include any chemical substance 
which was not manufactured or processed in the United States within 
three years before the effective date of the rules promulgated pur- 
suant to the last sentence of subsection (a) (1). In the case of a chemi- 
cal substance for which a notice is submitted in accordance with 
section 5, such chemical substance shall be included in such list as of 
the earliest date (as determined by the Administrator) on which such 
substance was manufactured or processed in the United States. The 
Administrator shall first publish such a list not later than 315 days 
after the effective date of this Act. The Administrator shall not include 
in such list any chemical substance which is manufactured or processed 
only in small quantities (as defined by the Administrator by rule) 
solely for purposes of scientific experimentation or analysis or chemi- 
cal research on, or analysis of, such substance or another substance, 
including such research or analysis for the development of a product. 

(2) To the extent consistent with the purposes of this Act, the 
Administrator may, in lieu of listing, pursuant to paragraph (1), a 
chemical substance individually, list a category of chemical substances 
in which such substance is included. 

(c) Records. — Any person who manufactures, processes, or distrib- 
utes in commerce any chemical substance or mixture shall maintain 
records of significant adverse reactions to health or the environment, 
as determined by the Administrator by rule, alleged to have been 
caused by the substance or mixture. Records of such adverse reactions 
to the health of employees shall be retained for a period of 30 years 
from the date such reactions were first reported to or known by the 
person maintaining such records. Any other record of such adverse 
reactions shall be retained for a period of five years frojii the date 
the information contained in the record was first reported to or known 
by the person maintaining the record. Records required to be main- 
tained under this subsection shall include records of consumer allega- 
tions of personal injury or harm to health, reports of occupational 
disease or injury, and reports or complaints of injury to the environ- 
ment submitted to the manufacturer, processor, or distributor in com- 
merce from any source. Upon request of any duly designated 
representative of the Administrator, each person who is required to 
maintain records under this subsection shall permit the inspection of 
such records and shall submit copies of such records. 

(d) Health and Safety Studies. — The Administrator shall pro- Rules, 
mulgate rules under which the Administrator shall require any person 

who manufactures, processes, or distributes in commerce or who pro- 
poses to manufacture, process, or distribute in commerce any chemical 
substance or mixture (or with respect to paragraph (2), any person 
who has possession of a study) to submit to the Administrator — 

(1) lists of health and safety studies (A) conducted or initiated 
by or for such person with respect to such substance or mixture 
at any time, (B) known to such person, or (C) reasonably ascer- 
tainable by such person, except that the Administrator may exclude 
certain types or categories of studies from the requirements of this 
subsection if the Administrator finds that submission of lists of 
such studies are unnecessary to carry out the purposes of this Act; 
and 

(2) copies of any study contained on a list submitted pursuant 
to paragraph (1) or otherwise known by such person. 

(e) Notice to Administrator of Substantial Risks. — ^Any person 
who manufactures, processes, or distributes in commerce a chemical 
substance or mixture and who obtains information which reasonably 



30 



90 STAT. 2030 PUBLIC LAW 94^9— OCT. 11, 1976 

supports the conclusion that such substance or mixture presents a 
substantial risk of injury to health or the environment shall imme- 
diately inform the Administrator of such information unless such 
person has actual knowledge that the Administrator has been ade- 
quately informed of such mformation. 

(f ) Definitions.— For purposes of this section, the terms "manufac- 
ture" and '"process'- mean manufacture or process for commercial 
purposes. 

SEC. 9. RELATIONSHIP TO OTHER FEDERAL LAWS. 

15 use 2608. (a) Laws Xot Administered by the Administrator. — (1) If 

the Administrator has reasonable basis to conclude that the manufac- 
ture, processing, distribution in commerce, use, or disposal of a chemical 
substance or mixture, or that any combination of such activities, pre- 
sents or will present an unreasonable risk of injury to health or the 
environment and determines, in the Administrator's discretion, that 
such risk may be prevented or reduced to a sufficient extent by action 
taken under a Federal law not administered by the Administrator, 

^^eport- the Administrator shall submit to the agency which administers such 

law a report which describes such risk and includes in such description 
a specification of the activity or combination of activities which the 
Administrator has reason to believe so presents such risk. Such report 
shall also request such agency — 

(A) (i) to determine if the risk described in such report may 
be prevented or reduced to a sufficient extent by action taken under 
such law, and 

(ii) if the agency determines that such risk may be so prevented 
or reduced, to issue an order declaring whether or not the activity 
or combination of activities specified in the description of such 
risk presents such risk ; and 

(B) to respond to the Administrator with respect to the matters 
described in subparagraph ( A ) . 

Publication in Any report of the Administrator shall include a detailed statement of 
Federal Register, the information on which it is based and shall be published in the 
Federal Register. The agency receiving a request under such a report 
shall make the requested determination, issue the requested order, 
and make the requested response within such time as the Administrator 
specifies in the request, but such time specified may not be less than 
90 days from the date the request was made. The response of an agency 
shall be accompanied by a detailed statement of the findings and 
conclusions of the agency and shall be published in the Federal Regis- 
ter. 

(2) If tlie Administrator makes a report under paragraph (1) with 
respect to a chemical substance or mixture and the agency to which 
such report was made either — 

(A) issues an order declaring that the activity or combination 
of activities specified in the description of the risk described in 
the report does not present the risk described in the report, or 

(B) initiates, within 90 days of the publication in the Federal 
Register of the response of the agency under paragraph (1 ) , action 
under the law (or laws) administered by such agency to protect 
against such risk associated with such activity or combination of 
activities, 

the .Administrator may not take any action imder section 6 or 7 with 
respect to such risk. 

(3) If the Administrator has initiated action under section 6 or 7 
with respect to a risk associated with a chemical substance or mixture 
which was the subject of a report made to an agency under paragraph 
(1), such agency shall before taking action under the law (or laws) 



31 



PUBLIC LAW 94-469— OCT. 11, 1976 90 STAT. 2031 

administered by it to protect against such risk consult with the Admin- 
istrator for the purpose of avoiding duplication of Federal action 
against such risk. 

(b) Laws Administered by the Administrator. — The Administra- 
tor shall coordinate actions taken under this Act with actions taken 
under other Federal laws administered in whole or in part by the 
Administrator. If the Administrator determines that a risk to health or 
the environment associated with a chemical substance or mixture could 
be eliminated or reduced to a sufficient extent by actions taken under 
tlie authorities contained in such other Federal laws, the Administrator 
shall use such authorities to protect against sucli risk unless the Admin- 
istrator determines, in the Administrator's discretion, that it is in the 
public interest to protect against such risk by actions taken under 
this Act. This subsection sluill not be construed to relieve the Admin- 
istrator of any requirement imposed on the Administrator by such 
other Federal laws. 

(c) Oc^cuPATTONAL Satoty AND Health. — lu exercising any author- 
ity under this Act, the Administrator shall not, for purposes of section 

4(b)(1) of the Occupational Safety and Health Act of 1970, be 29 USC 651 note, 
deemed to be exercising statutory authority to prescribe or enforce 
standards or regulations affecting occupational safety and health. 

(d) Coordination. — In administering this Act, the Administrator 
shall consult and coordinate with tlie Secretary of Health, Education, 
and Welfare and the heads of any other appropriate Federal execu- 
tive department or agency, any relevant independent regulatory 
agency, and any other appropriate instrumentality of the Federal Gov- 
ernment for the purpose of achieving the maximum enforcement of this 
Act while imposing the least burdens of duplicative requirements on 
those subject to the Act and for other purposes. The Administrator 
shall, in the report required by section 30, report, annually to the 
Congress on actions taken to coordinate with such other Federal 
departments, agencies, or instrumentalities, and on actions taken to 
coordinate the authority imder this Act with the authority granted 
under other Acts leferred to in subsection (b). 

SEC. 10. RESEARCH. DEVELOPMENT, COLLECTION, DISSEMINATION, 
AND UTILIZATION OF DATA. 

(a) Authority.— The Administratoi- shall, in consultation and 15 USC 2609. 
cooperation with the Secretary of Health, Education, and Welfare 

and with other heads of appropriate departments and agencies, con- 
duct such research, development, and monitoring as is necessary to 
carry out the purposes of tliis Act. The Administrator may enter into 
contracts and may make grants for resesirch, development, and moni- 
toring under this subsection. Contracts may be entered into under this 
subsection without regard to sections 3648 and 3709 of the Revised 
Statutes (31 U.S.C. 529, 14 U.S.C. 5). 

(b) Data Systems. — (1) The Administrator shall establish, admin- 
ister, and be responsible for the continuing activities of an interagency 
committee which shall design, establish, and coordinate an efficient and 
effective system, within the Environmental Protection Agency, for 
the collection, dissemination to other Federal departments and agen- 
cies, and use of data submitted to the Administrator under this Act. 

(2) (A) The Administrator shall, in consultation and cooperation 
with the Secretary of Health, Education, and Welfare and other heads 
of appropriate departments and agencies design, establish, and coordi- 
nate an efficient and effective system for the retrieval of toxicological 
and other scientific data which could be useful to the Administrator in 
carrying out the purposes of this Act. Systematized retrieval shall be 
developed for use by all Federal and other departments and agencies 



32 



90 STAT. 2032 PUBLIC LAW 94-469— OCT. 11, 1976 

with responsibilities in the area of regulation or study of chemical 
substances and mixtures and their effect on health or the environment. 

(B) The Administrator, in consultation and cooperation with the 
Secretary of Health, Education, and Welfare, may make grants and 
enter into contracts for the development of a data retrieval system 
described in subparagraph (A). Contracts may be entered into under 
this subparagraph without regard to sections 3648 and 3709 of the 
Revised Statutes (31 U.S.C. 529, 41 U.S.C. 5) . 

(c) Screening Techniques. — The Administrator shall coordinate, 
with the Assistant Secretary for Health of the Department of Health, 
Education, and Welfare, research imdertaken by the Administrator 
and directed toward the development of rapid, reliable, and economical 
screening techniques for carcinogenic, mutagenic, teratogenic, and 
ecological effects of chemical substances and mixtures. 

(d) Monitoring. — The Administrator shall, in consultation and 
cooperation with the Secretary of Health, Education, and Welfare, 
establish and be responsible for research aimed at the development, in 
cooperation with local, State, and Federal agencies, of monitoring 
techniques and instruments which may be used in the detection of toxic 
chemical substances and mixtures and which are reliable, economical, 
and capable of being implemented under a wide variety of conditions. 

(e) Basic Research. — The Administrator shall, in consultation and 
cooperation with the Secretary of Health, Education, and Welfare, 
establish research programs to develop the fundamental scientific basis 
of the screening and monitoring techniques described in subsections 
(c) and (d), the bounds of the reliability of such techniques, and the 
opportunities for their improvement. 

(f) Training. — The Administrator shall establish and promote 
programs and workshops to train or facilitate the training of Federal 
laboratory and technical personnel in existing or newly developed 
screening and monitoring techniques. 

(g) Exchange of Research and Development Results. — The 
Administrator shall, in consultation with the Secretary of Health, 
Education, and Welfare and otlier heads of appropriate departments 
and agencies, establish and coordinate a system for exchange ainong 
Federal, State, and local authorities of research and development 
results respecting toxic chemical substances and mixtures, including 
a system to facilitate and promote the development of standard data 
format and analysis and consistent testing procedures. 

SEC. 11. INSPECTIONS AND SUBPOENAS. 
15 use 2610. (a) In General. — For purposes of administering this Act, the 

Administrator, and any duly designated representative of the Admin- 
istrator, may inspect any establishment, facility, or other premises in 
which chemical substances or mixtures are manufactured, processed, 
stored, or held before or after their distribution in commerce and any 
conveyance being used to transport chemical substances, mixtures, or 
such articles in connection with distribution in commerce. Such an 
inspection may only be made upon the presentation of appropriate 
credentials and of a written notice to the owner, operator, or agent in 
charge of the premises or conveyance to be inspected. A separate notice 
shall be given for each such inspection, but a notice shall not be 
resquired for each entry made during the period covered by the inspec- 
tion. Each such inspection shall be commenced and completed with 
reasonable promptness and shall be conducted at reasonable times, 
within reasonable limits, and in a reasonable manner. 

(b) Scope. — (1) Except as provided in paragraph (2), an inspec- 
tion conducted under subsection (a) shall extend to all things within 



33 



PUBLIC L.\W 94-469— OCT. 11, 1976 90 STAT. 2033 

the premises or conveyance inspected (including records, files, papers, 
processes, controls, and facilities) bearing on whether the requirements 
of this Act applicable to the chemical substances or mixtures within 
such premises or conveyance have been complied with. 
(2) No inspection under subsection (a) shall extend to — 
(A) financial data, 

B ) sales data ( other than shipment data ) , 

C) pricing data, 

(D) personnel data, or 

(E) research data (other than data required by this Act or 
under a rule promulgated thereunder) , 

unless the nature and extent of such data are described with reasonable 
specificity in the written notice required by subsection (a) for such 
inspection. 

(c) Subpoenas. — In carrying out this Act, the Administrator may 
by subpoena require the attendance and testimony of witnesses and 
the production of reports, papers, documents, answei"s to questions, 
and otlier information that the Administrator de-ems necessary. Wit- 
nesses shall be paid the same fees and mileage that are paid witnesses 
in the courts of the United States. In the event of contumacy, failure, 
or refusal of any person to obey any such subpoena, any district court 
of the United States in which venue is proper shall have jurisdiction 
to order any such jxM-son to comply with such subpoena. Any failure 
to obey such an order of the court is punishable by the court as a con- 
tempt thereof. 

SEC. 12. EXPORTS. 

(a) In Gener.\l. — (1) Except as provided in paragraph (2) and 15USC2611. 
subsection (b), this Act (other than se<!tion 8) shall not apply to any 

chemical substance, mixture, or to an article containing a chemical 
substance or mixture, if — 

(A) it can be shown that such substance, mixture, or article is 
being manufactured, processed, or distributed in commerce for 
export from the United States, unless such substance, mixture, or 
article was, in fact, manufactured, processed, or distributed in 
commerce, for use in the United States, and 

(B) such substance, mixture, or article (when distributed in 
commerce), or any container in which it is enclosed (when so dis- 
tributed), bears a stamp or label stating that such substance, mix- 
ture, or article is intended for export. 

(2) Paragraph (1) shall not apply to any chemical substance, mix- 
ture, or article if the Administrator finds that the substance, mixture, 
or article will present an unreasonable risk of injury to health within 
the United States or to the environment of the United States. The 
Administrator may require, under section 4, testing of any cliemical 
substance or mixture exempted from this Act by paragraph (1) for 
the purpose of determining whether or not such substance or mixture 
presents an unreasonable risk of injury to health within the United 
States or to the environment of the United States. 

(b) Notice. — (1) If any person exports or intends to export to a 
foreign country a chemical substance or mixture for which the submis- 
sion of data is required under section 4 or 5(b), such person shall 
notify the Administrator of such exportation or intent to export and 
the Administrator shall furnish to the government of such country 
notice of the availability of the data submitted to the Administrator 
under such section for such substance or mixture. 

(2) If any person exports or intends to export to a foreign country 
a chemical substance or mixture for which an order has been issued 



34 



90 STAT. 2034 PUBLIC LAW 94-469— OCT. 11, 1976 

under section 5 or a rule has been proposed or promulgated under sec- 
tion 5 or 6, or with respect to which an action is pending, or relief has 
been granted under section 5 or 7, such person shall notify the Admin- 
istrator of such exportation or intent to export and the Administrator 
shall furnish to the government of such country notice of such rule, 
order, action, or relief. 

SEC. 13. ENTRY INTO CUSTOMS TERRITORY OF THE UNITED STATES. 

15 use 2612. (a) Ix General. — (1) The Secretary of the Treasury shall refuse 

entry into the customs territory of the United States (as defined in 

19 use 1202. genei al headnote 2 to the Tariff Schedules of the United States) of 
any chemical substance, mixture, or article containing a chemical sub- 
stance or mixture offered foi- such entry if — 

(A) it fails to comply with any rule in effect under this Act, or 

(B) it is offered for entry in violation of section 5 or 6, a rule or 
order under section 5 or 6, or an order issued in a civil action 
brought under section 5 or 7. 

Notification. (2) If a chemical substance, mixture, or article is refused entry 

under paragraph (1), the Secretary of the Treasury shall notify the 
consignee of such entry refusal, shall not release it to the consignee, 
and shall cause its disposal or storage (under such rules as the Secre- 
tary of the Treasury may prescribe) if it has not been exported by the 
consignee within 90 days from the date of receipt of notice of such 
refusal, except that the Secretary of the Treasury may, pending a 
review by the Administrator of the entry refusal, release to the con- 
signee such substance, mixture, or article on execution of bond for the 
amount of the full invoice of such substance, mixture, or article (as 
such value is set forth in the customs entry), together with the duty 
thereon. On failure to return such substance, mixture, or article for 
any cause to the custody of the Secretary of the Treasury when 
demanded, such consignee shall be liable to the L'nited States for liqui- 
dated damages equal to the full amount of such bond. All charges for 
storage, cartage, and labor on and for disposal of substances, mixtures, 
or articles which are refused entry or release under this section shall 
be paid by the owner or consignee, and in default of such payment 
shall constitute a lien against any future entry made by such owner or 
consignee. 

(b) Rules. — The Secretary of the Treasury, after consultation with 
the Administrator, shall issue rules for the administration of subsec- 
tion (a) of this section. 
SEC. 14. DISCLOSURE OF DATA. 
15 use 2613. (a) In General. — Except as provided by subsection (b), any 

information reported to, or otherwise obtained by, the Administrator 
(or any representative of the Administrator) under this Act, which is 
exempt from disclosure pursuant to subsection (a) of section 552 of 
title 5, United States Code, by reason of subsection (b) (4) of such 
section, shall, notwithstanding the provisions of an}' other section of 
this Act, not be disclosed by the Administrator or by any officer or 
employee of the United States, except that such information — 

(1) shall be disclosed to any officer or employee of the United 
States— 

(A) in connection with the official duties of such officer 
or employee under any law for the protection of health or 
the environment, or 

(B) for specific law enforcement purposes ; 

(2) shall be disclosed to contractors with the United States and 
employees of such contractors if in the opinion of the Administra- 



35 



PUBLIC LAW 94-469— OCT. 11, 1976 90 STAT. 2035 

tor such disclosure is necessary for the satisfactory performance 
by the contractor of a contract with the United States entered into 
on or after the date of enactment of this Act for the performance 
of work in connection with this Act and under such conditions 
as the Administrator may specify ; 

(3) shall be disclosed if the Administrator determines it neces- 
sary to protect health or tlie environment against an unreasonable 
risk of injury to health or the environment ; or 

(4) may Ibe disclosed when relevant in any proceeding under 
this Act, except that disclosure in such a proceeding shall be 
made in such manner as to preserve confidentiality to the extent 
practicable without impairing tlie proceeding. 

In any proceeding under section 552(a) of title 5, United States Code, 
to obtain information the disclosure of which lias been denied because 
of the provisions of this subsection, the Administrator may not rely on 
section 55*2(1)} (3) of such title to sustain the Administrator's action. 

(b) Data From Health and Safety Studies. — (1) Subsection (a) 
does not prohibit the disclosure of — 

(A) any health and safety study which is submitted under this 
Act with respect to — 

(i) any chemioal substance or mixture which, on the date 
on which such study is to be disclosed has been offered for 
commercial distribution, or 

(ii) any chemical substance or mixture for which testing is 
required under section 4 or for which notification is required 
under section 5, and 

(B) any data reported to. or otherwise obtained by, the Admin- 
istrator from a health and safety study which relates to a chemical 
substance or mixture described in clause (i) or (ii) of subpara- 
graph (A). 

This paragraph does not authorize the release of any data which dis- 
closes processes used in the manufacturing or processing of a chemical 
substance or mixture or, in the case of a mixture, the release of data 
disclosing the portion of the mixture comprised by any of the chemical 
substances in the mixture. 

(2) If a request is made to the Administrator under subsection (a) 
of section 552 of title 5, United States Code, for information which is 
described in the first sentence of paragraph (1) and which is not 
information described in the second sentence of such paragraph, the 
Administrator may not deny such request on the basis of subsection 
(b) (4) of such section. 

(c) I)est(;nati()x and Release of Confidential Data. — (1) In sub- 
mitting data under this Act, a manufacturer, processor, or distributor 
in commerce may (A) designate the data which such person believes 
is entitled to confidential treatment under subsection (a), and (B) 
submit such designated data separately from other data submitted 
under this Act. A designation under this paragraph shall be made in 
writing and in such manner as the Administrator may prescribe. 

(2) (A) Except as provided by subparagraph (B), if the Adminis- 
trator proposes to release for inspection data which has been desig- 
nated under paragraph (1)(A). the Administrator shall notify, in 
writing and by certified mail, the manufacturer, processor, or distrib- 
utor in commerce who submitted such data of the intent to release such 
data. If the release of siich data is to be made pursuant to a request 
made under section 552(a) of title 5, United States Code, such notice 
shall be given immediateh' upon approval of such request by the 
Administrator. The Administrator may not release such data until 



36 



90 STAT. 2036 PUBLIC LAW 94-469— OCT. 11, 1976 

the expiration of 30 days after the manufacturer, processor, or distrib- 
utor in commerce submitting such data has received the notice required 
by this subparagraph. 
Notification. (B) (i) Subparagraph (A) shall not apply to the release of infor- 

mation under paragraph (1), (2), (3), or (4) of subsection (a), except 
that the Administrator may not release data under paragraph (3) of 
subsection (a) unless the Administrator has notified each manufac- 
turer, processor, and distributor in commerce who submitted such data 
of such release. Such notice shall be made in writing by certified mail 
at least 15 days before the release of such data, except that if the 
Administrator determines that the release of such data is necessary 
to protect against an imminent, unreasonable risk of injury to health 
or the environment, such notice may be made by such means as the 
Administrator determines will provide notice at least 24 hours before 
such release is made. 

(ii) Subparagraph (A) shall not apply to the release of information 
described in subsection (b)(1) other than information described in 
the second sentence of such subsection. 

(d) Criminal Penalty for Wrongfut^ Disclosure. — (1) Any 
officer or employee of the United States or former officer or employee 
of the United States, who by virtue of such employment or official 
position has obtained possession of, or has access to, material the dis- 
closure of which is prohibited by subsection (a), and who knowing 
that disclosure of such material is prohibited by such subsection, will- 
fully discloses the material in any manner to any person not entitled to 
receive it, shall be guilty of a misdemeanor and fined not more than 
$5,000 or imprisoned for not more than one year, or both. Section 
1905 of title 18, United States Code, does not apply with respect to 
the publishing, divulging, disclosure, or making known of, or making 
available, information reported or otherwise obtained under this Act. 

(2) For the purposes of paragraph (1), any contractor with the 
United States who is furnished information as authorized by subsec- 
tion (a) (2), and any employee of any such contractor, shall be con- 
sidered to be an employee of the United States. 

(e) Access by Congress. — Notwithstanding any limitation con- 
tained in this section or any other provision of law, all information 
reported to or otherwise obtained by the Administrator (or any repre- 
sentative of the Administrator) under this Act shall be made available, 
upon written request of any duly authorized committee of the Con- 
gress, to such committee. 

SEC. 15. PROHIBITED ACTS. 
15 use 2614. It shall be unlawful for any person to — 

(1) fail or refuse to comply with (A) any rule promulgated or 
order issued under section 4, (B) any requirement prescribed by 
section 5 or 6, or (C) any rule promulgated or order issued under 
section 5 or 6 ; 

(2) use for commercial purposes a chemical substance or mix- 
ture which such person knew or had reason to know was manufac- 
tured, processed, or distributed in commerce in violation of section 
5 or 6, a rule or order under section 5 or 6, or an order issued in 
action brought under section 5 or 7 ; 

(3) fail or refuse to (A) establish or maintain records, (B) 
submit reports, notices, or other information, or (C) permit access 
to or copying of records, as required by this Act or a rule there- 
under; or 

(4) fail or refuse to permit entry or inspection as required by 
section 11. 



37 



PUBLIC LAW 94-469— OCT. 11, 1976 90 STAT. 2037 

SEC. 16. PENALTIES. 

(a) Civil. — (1) Any person who violates a provision of section 15 15 USC 2615. 
shall be liable to the United States for a civil penalty in an amount 

not to exceed $25,000 for each such violation. Each day such a viola- 
tion continues shall, for purposes of this subsection, constitute a sepa- 
rate violation of section 15. 

(2) (A) A civil penalty for a violation of section 15 shall be assessed Hearing, 
by the Administrator by an order made on the record after oppor- 
tunity (provided in accordance with this subparagraph) for a hearing 

in accordance with section 554 of title 5, United States Code. Before 
issuing such an order, the Administrator shall give written notice to 
the person to be assessed a civil penalty under such order of the Admin- 
istrator's proposal to issue such order and provide such person an 
opportunity to request, within 15 days of the date the notice is received 
by such person, such a hearing on the order. 

(B) In determining the amount of a civil penalty, the Administra- 
tor shall take into account the nature, circumstances, extent, and 
gravity of the violation or violations and, with respect to the violator, 
ability to pay, effect on ability to continue to do business, any history 
of prior such violations, the degree of culpability, and such other 
matters as justice may require. 

(C) The Administrator may compromise, modify, or remit, with 
or without conditions, any civil penalty which may be imposed under 
this subsection. The amount of such penalty, when finally determined, 
or the amount agreed upon in compromise, may be deducted from 
any sums owing by the United States to the person charged. 

(3) Any person who requested in accordance with paragraph (2) Petition for 
(A) a hearing respecting the assessment of a civil penalty and who is judicial review, 
aggrieved by an prder asse^sin^ a civil penalty may file a petition for 

judicial review of such order with the United States Court of Appeals 
for the District of Columbia Circuit or for any other circuit in which 
such person resides or transacts business. Such a petition may only be 
filed within the 30-day period beginning on the date the order making 
such assessment was issued. 

(4) If any person fails to pay an assessment of a civil penalty — 

(A) after the order making the assessment has become a final 
order and if such person does not file a petition for judicial review 
of the order in accordance with paragraph (3), or 

(B) after a court in an action brought under paragraph (3) 
has entered a final judgment in favor of the Administrator, 

the Attorney General shall recover the amount assessed (plus interest 
at currently prevailing rates from the date of the expiration of the 30- 
day period referred to in paragraph (3) or the date of such final 
judgment, as the case may be) in an action brought in any appropriate 
district court of the United States. In such an action, the validity, 
amount, and appropriateness of such penalty shall not be subject to 
review. 

(b) Criminal. — Any person who knowingly or willfully violates 
any provision of section 15 shall, in addition to or in lieu of any civil 
penalty which may be imposed under subsection (a) of this section for 
such violation, be subject, upon conviction, to a fine of not more than 
$25,000 for each day of violation, or to imprisonment for not more 
than one year, or both. 

SEC. 17. SPECIFIC ENFORCEMENT AND SEIZURE. 

(a) Specific Enforcement. — (1) The district courts of the United 15 USC 2616. 
States shall have jurisdiction over civil actions to — 
(A) restrain any violation of section 15, 



38 



90 STAT. 2038 PUBLIC LAW 94-469— OCT. 11, 1976 

(B) restrain any person from taking any action prohibited by 
section 5 or 6 or by a rule or order under section 5 or 6, 

(C) compel the taking of any action required by or under this 
Act, or 

(D) direct any manufacturer or processor of a chemical sub- 
stance or mixture manufactured or processed in violation of sec- 
tion 5 or 6 or a rule or order under section 5 or 6 and distributed 
in commerce, (i) to give notice of such fact to distributors in 
commerce of such substance or mixture and, to the extent reason- 
ably ascertainable, to other persons in possession of such sub- 
stance or mixture or exposed to such substance or mixture, (ii) to 
give public notice of such risk of injury, und (iii) to either replace 
or repurchase such substance or mixture, whichever the person to 
which the requirement is directed elects. 

(2) A civil action described in paragraph ( 1 ) may be brought — 

(A) in the case of a civil action described in subparagraph (A) 
of such paragraph, in the United States district court for the judi- 
cial district wherein any act, omission, or transaction constituting 
a violation of section 15 occurred or wherein the defendant is found 
or transacts business, or 

(B) in the case of any other civil action described in such para- 
graph, in the United States district court for the judicial district 
wherein the defendant is found or transacts business. 

In any such civil action process may be served on a defendant in any 
judicial district in which a defendant resides or may be found. Sub- 
poenas requiring attendance of witnesses in any such action may be 
served in any judicial district. 

(b) Seizure. — Any chemical substance or mixture which was manu- 
factured, processed, or distributed in commerce in violation of this Act 
or any rule promulgated or order issued under this Act or any article 
containing such a substance or mixture shall be liable to be proceeded 
against, by process of libel for the seizure and condemnation of such 
substance, mixture, or article, in any district court of the United States 
within the jurisdiction of which such substance, mixture, or article is 
found. Such proceedings shall conform as nearly as possible to proceed- 
ings in rem in admiralty. 
SEC. 18. PREEMPTION. 
15 use 2617. (a) Effect on State Law. — (1) Except as provided in paragraph 

(2) , nothing in this Act shall affect the authority of any State or politi- 
cal subdivision of a State to establish or continue in effect regulation 
of any chemical substance, mixture, or article containing a chemical 
substance or mixture. 

(2) Except as provided in subsection (b) — 

(A) if the Administrator requires by a rule promulgated under 
section 4 the testing of a chemical substance or mixture, no State or 
political subdivision may, after the effective date of such rule, 
establish or continue in effect a requirement for the testing of such 
substance or mixture for purposes similar to those for which test- 
ing is required under such rule ; and 

(B) if the Administrator prescribes a rule or order under sec- 
tion 5 or 6 (other than a rule imposing a requirement deecrilDed 
in subsection (a) (6) of section 6) which is applicable to a chemical 
substance or mixture, and which is designed to protect against a 
risk of injury to health or the environment associated with such 
substance or mixture, no State or political subdivision of a State 
may, after the effective date of such requirement, establish or 
continue in effect, any requirement which is applicable to such sub- 
stance or mixture, or an article containing such substance or mix- 



39 



PUBLIC LAW 94-469~0CT. 11, 1976 



90 STAT. 2039 



Petition. 
15 use 2618. 



ture, and which is designed to protect against such risk unless such 
requirement (i) is identical to the requirement prescribed by the 
Administrator, (ii) is adopted under the authority of the Clean 
Air Act or any other Federal law, or (iii) prohibits the use of such 
substance or mixture in such State or political subdivision (other 
than its use in the manufacture or processing of other substances 
or mixtures). 

(b) Exemption. — Upon application of a State or political subdivi- Application, 
sion of a State the Administrator may by rule exempt from subsection 
(a)(2), under such conditions as may be prescribed in such rule, a 
requirement of such State or political subdivision designed to protect 
against a risk of injury to health or the environment associated with 
a chemical substance, mixture, or article containing a chemical sub- 
stance or mixture if — 

(1) compliance with the requirement would not cause the 
manufacturing, processing, distribution in commerce, or use of the 
substance, mixture, or article to be in violation of the applicable 
requirement under this Act described in subsection (a)(2), and 
^2) the State or political subdivision requirement (A) provides 
a significantly higher degree of protection from such risk than the 
requirement under this Act described in subsection (a)(2) and 
(B) does not, through difficulties in marketing, distribution, or 
other factors, unduly burden interstate commerce. 
SEC. 19. JUDICUL REVIEW. 

(a) In Gener.\l. — (1)(A) Not later than 60 days after the date 
of the promulgation of a rule under section 4(a), 5(a) (2), 5(b) (4), 
6(a), 6(e), or 8, any person may file a petition for judicial review of 
such rule with the United States Court of Appeals for the District of 
Columbia Circuit or for the circuit in which such person resides or in 
wliich such person's principal place of business is located. Courts 
of appeals of the Ignited States shall have exclusive jurisdiction of 
any action to obtain judicial review (other tlian in an enforcement 
proceeding) of such a rule if any district court of the United States 
would liave had jurisdiction of such action but for this subparagraph. 

(R) Courts of appeals of the United States shall have exclusive 
jurisdiction of any action to obtain judicial review (other than in an 
enforcement proceeding) of an order issued under subparagraph (A) 
or (B) of sectioft 6(b)(1) if any district court of the United States 
would have had jurisdiction of such action but for this subparagraph. 

(2) Copies of any petition filed under paragraph (1)(A) sliall he 
transmitted forthwith to the Administrator and to the Attorney Gen- 
eral by the clerk of the court with which such petition was filed. The 
provisions of section 2112 of title 28, United States Code, shall apply 
to the filing of the rulemaking record of proceedings on which the 
Administrator based the rule being reviewed under this section and to 
the transfer of proceedings between United States courts of appeals. 

(3) For purposes of this section, the term "rulemaking record" 
means — 

(A) the rule being reviewed under this section ; 

(B) in the case of a rule under section 4(a) , the finding required 
by such section, in the case of a rule under section 5(b) (4), the 
finding required by such section, in the case of a rule under section 
6(a) the finding required by section 5(f) or 6(a), as the case may 
be, in the case of a rule under section 6(a) , the statement required 
by section 6(c) (1), and in the case of a rule under section 6(e), 
the findings required by paragraph (2)(B) or (3)(B) of such 
section, as the case may be ; 



Jurisdiction. 



Petition copies, 
transmittal to 
Administrator 
and Attorney 
General. 



"Rulemaking 
record." 



40 



90 STAT. 2040 



PUBLIC LAW 94-469— OCT. 11, 1976 



Notice, 

publication in 
Federal Register. 



Review. 



(C) any transcript required to be made of oral presentations 
made in proceedings for the promulgation of such rule ; 

(D) any written submission of interested parties respecting the 
promulgation of such rule ; and 

(E) any other information which the Administrator considers 
to be relevant to such rule and which the Administrator identified, 
on or before the date of the promulgation of such rule, in a notice 
published in the Federal Register. 

(b) Additional Submissions and Presentations ; Modifications. — 
If in an action under this section to review a rule the petitioner or the 
Administrator applies to the court for leave to make additional oral 
submissions or written presentations respecting such rule and shows 
to the satisfaction of the court that such submissions and presentations 
would be material and that there were reasonable grounds for the sub- 
missions and failure to make such submissions and presentations in 
the proceeding before the Administrator, the court may order the 
Administrator to provide additional opportunity to make such sub- 
missions and presentations. The Administrator may modify or set 
aside the rule being reviewed or make a new rule by reason of the 
additional submissions and presentations and shall file such modified 
or new rule with the return of such submissions and presentations. 
The court shall thereafter review such new or modified rule. 

(c) Standard of Review. — (1) (A) Upon the filing of a petition 
under subsection (a) (1) for judicial review (,f a rule, the court shall 
have jurisdiction (i) to grant appropriate relief, includiBg interim 
relief, as provided in chapter 7 of title 5, United States Code, and 
(ii) except as otherwise provided in subparagraph (B), to review 
such rule in accordance with chapter 7 of title 5, United States Code. 

(B) Section 706 of title 5, United States Code, shall apply to review 
of a rule under this section, except that — 

(i) in the case of review of a rule under section 4(a), 5(b) (4), 
6(a), or 6(e), the standard for review prescribed by paragraph 
(2) (E) of such section 706 shall not apply and the court shall 
hold unlawful and set aside such rule if the court finds that the 
rule is not supported by substantial evidence in the rulemaking 
record (as defined in subsection (a)(3)) taken as a whole; 

(ii) in the case of review of a rule under section 6(a), the court 
shall hold unlawful and set aside such rule if it finds that— 

(I) a determination by the Administrator under section 
6(c) (3) that the petitioner seeking review of such rule is not 
entitled to conduct (or have conducted) cross-examination or 
to present rebuttal submissions, or 

(II) a rule of, or ruling by, the Administrator under sec- 
tion 6(c) (3) limiting such petitioner's cross-examination or 
oral presentations, 

has precluded disclosure of disputed material facts which was 
necessary to a fair determination by the Administrator of the 
rulemaking proceeding taken as a whole; and section 706(2) (D) 
shall not apply with respect to a determination, rule, or ruling 
referred to in subclause (I) or (II) ; and 

(iii) the court may not review the contents and adequacy of— 

(I) any statement required to be made pursuant to section 
6(c)(1), or 

(II) any statement of basis and purpose required by sec- 
tion 553(c) of title 5, United States Code, to be incorporated 
in the rule 

except as part of a review of the rulemaking record taken as a 
whole. 



41 



PUBLIC LAW 94-469— OCT. 11, 1976 90 STAT. 2041 

The term "evidence" as used in clause (i) means any matter in the "Evidence." 
rulemaking record. 

(C) A determination, rule, or ruling of the Administrator described 
in suDparagraph (B)(ii) may be reviewed only in an action under 
this section and only in accordance with such subparagraph. 

(2) The judgment of the court affirming or setting aside, in whole 
or in part, any rule reviewed in accordance with this section sliall be 
final, subject to review by the Supreme Court of the United States 
upon certiorari or certification, as provided in section 1254 of title 28, 
United States Code. 

(d) Fees and costs. — The decision of the court in an action com- 
menced under subsection (a), or of the Supreme Court of the United 
States on review of such a decision, may include an award of costs of 
suit and reasonable fees for attorneys and expert witnesses if the court 
determines that such an award is appropriate. 

(e) Other remedies. — The remedies as provided in this section shall 
be in addition to and not in lieu of any other remedies provided by law. 
SEC. 20. CITIZENS' CIVIL ACTIONS. 

(a) In General. — Except as provided in subsection (b) , any person 15 USC 2619. 
may commence a civil action — 

(1) against any person (including (A) the United States, and 
(B) any other governmental instrumentality or agency to the 
extent permitted by the eleventh amendment to the Constitution) 
who is alleged to be in violation of this Act or any. rule promul- 
gated imder section 4, 5, or 6 or order issued under section 5 
to restrain such violation, or 

(2) against the Administrator to compel the Administrator 
to perform any act or duty under this Act which is not discre- 
tionary. 

Any civil action under paragraph (1) shall be brought in the United 
States district court for the district in which the alleged violation 
occurred or in which the defendant resides or in which the defendant's 
principal place of business is located. Any action brought under para- 
graph (2) shall be brought in the United States District Court for 
the District of Columbia, or the United States district court for the 
judicial district in which the plaintiff is domiciled. The district courts Jurisdiction, 
of the United States shall have jurisdiction over suits brought under 
this section, without regard to the amount in controversy or the citizen- 
ship of the parties. In any civil action under this subsection process 
may be served on a defendant in any judicial district in which the 
defendant resides or may be found and subpoenas for witnesses may 
be served in any judicial district. 

(b) LiMrrATioN. — No civil action may be commenced — 

(1) under subsection (a) (1) to restrain a violation of this Act 
or rule or order under this Act — 

(A) before the expiration of 60 days after the plaintiff Notice, 
has given notice of such violation (i) to the Administrator, 

and (ii) to the person who is alleged to have committed such 
violation, or 

(B) if the Administrator has commenced and is diligently 
prosecuting a proceeding for the issuance of an order under 
section 16(a) (2) to require compliance with this Act or with 
such rule or order or if the Attorney General has commenced 
and is diligently prosecuting a civil action in a court of the 
United States to require compliance with this Act or with 
such rule or order, but if such proceeding or civil action is 
commenced after the giving of notice, any person giving such 
notice may intervene as a matter of right in such proceeding 
or action ; or 



79-313 O - 77 - 4 



42 



90 STAT. 2042 PUBLIC LAW 94-469--0CT. 11, 1976 

Notice. (2) under subsection (a) (2) before the expiration of 60 days 

after the plaintiff has given notice to the Administrator of the 
alleged failure of the Administrator to perform an act or duty 
which is the basis for such action or, in the case of an action under 
such subsection for the failure of the Administrator to file an 
action under section 7, before the expiration of ten days after 
such notification. 

Rule. Notice under this subsection shall be given in such manner as the 

Administrator shall prescribe by rule. 

(c) General. — (1) In any action under this section, the Adminis- 
trator, if not a party, may intervene as a matter of right. 

(2) The court, in issuing any final order in any action brought pur- 
suant to subsection (a), may award costs of suit and reasonable fees 
for attoineys and expert witnesses if the court determines that such 
an award is appropriate. Any court, in issuing its decision in an action 
brought to review such an order, may award costs of suit and reason- 
able fees for attorneys if the court determines that such an award 
is appropriate. 

(3) Xothing in this section shall restrict any right which any person 
(or class of persons) may have under any statute or common law to 
seek enforcement of this Act or any rule or order under this Act 
or to seek any other relief. 

(d) Consolidation. — When two or more civil actions brought under 
subsection (a) involving the same defendant and the Si{m^ issues or 
violations are pending in two or more judicial districts, «uch pending 
actions, upon application of such defendants to such actions which is 
made to a court in which any such action is brought, may, if such court 
in its discretion so decides, be consolidated for trial by order (issued 
after giving all parties reasonable notice and opportunity to be heard) 
of such court and tried in — 

(1) any district which is selected by such defendant and in 
which one of such actions is pending, 

(2) a district which is agreed upon by stipulation between all 
the parties to such actions and in which one of such actions is 
pending, or 

(3) a district which is selected by the court and in which one 
of such actions is pending. 

The court issuing such an order shall give prompt notification of the 
order to the other courts in which the civil actions consolidated under 
the order are pending. 
SEC. 21. CITIZENS' PETITIONS. 
15 use 2620. (a) In General. — Any person may petition the Administrator to 

initiate a proceeding for the issuance, amendment, or repeal of a rule 
under section 4, 6, or 8 or an order under section 5(e) or (6) (b) (2). 

(b) Procedures. — (1) Such petition shall be filed in the principal 
office of the Administrator and shall set forth the facts which it is 
claimed establish that it is necessary to issue, amend, or repeal a rule 
under section 4, 6, or 8 or an order under section 5(6), 6(b) (1) (A), 
or 6(b)(1)(B). 

Public hearing. (2) The Administrator may hold a public hearing or may conduct 

such investigation or proceeding as the Administrator deems appro- 
priate in order to determine whether or not such petition should be 
granted. 

(3) "Within 90 days after filing of a petition described in paragraph 
(1), the Administrator shall either grant or deny the petition. If the 
Administrator grants such petition, the Administrator shall promptly 



43 



PUBLIC LAW 94-469— OCT. 11, 1976 90 STAT. 2043 

commence an appropriate proceeding in accordance with section 4, 
5, 6, or 8. If the Administrator denies such petition, the Administrator Publication in 
shall publish in the Federal Register the Administrator's reasons Fe<leral Register, 
for such denial. 

(4) (A) If the Administrator denies a petition filed under this CivU action, 
section (or if the Administrator fails to grant or deny such petition 

within the 90-day period) the petitioner may commence a civil action 
in a district court of the United States to compel the Administrator 
to initiate a rulemaking proceeding as requested in the petition. Any 
such action shall be filed within 60 days after the Administrator's 
denial of the petition or, if the Administrator fails to grant or deny 
the petition within 90 days after filing the petition, within 60 days 
after the expiration of the 90-day period. 

(B) In an action under subparagraph (A) respecting a petition 
to initiate a proceeding to issue a rule under section 4, 6, or 8 or an 
order under section 5(e) or 6(b) (2), the petitioner shall be provided 
an opportunity to have such petition considered by the court in a 
de novo proceeding. If the petitioner demonstrates to the satisfaction 
of the court by a preponderance of the evidence that — 

(i) in the case of a petition to initiate a proceeding for the 
issuance of a rule under section 4 or an order under section 5(e) — 

(I) information available to the Administrator is insuffi- 
cient to permit a reasoned evaluation of the health and 
environmental effects of the chemical substance to be subject 
to such rule or order; and 

(II) in the absence of such information, the substance may 
present an unreasonable risk to health or the environment, 
or the substance is or will be produced in substantial quan- 
tities and it enters or may reasonably be anticipated to enter 
the environment in substantial quantities or there is or may 
be significant or substantial human exposure to it; or 

(ii) in the case of a petition to initiate a proceeding for the 
issuance of a rule under section 6 or 8 or an order under section 
6(b) (2), there is a reasonable basis to conclude that the issuance 
of such a rule or order is necessary to protect health or the 
environment against an unreasonable risk of injury to health or 
the environment. 

the court shall order the Administrator to initiate the action requested 
by the petitioner. If the court finds that the extent of the risk to 
health or the environment alleged by the petitioner is less than the 
extent of risks to health or the environment with respect to which 
the Administrator is taking action under this Act and there are 
insufficient resources available to the Administrator to take the action 
requested by the petitioner, the court may permit the Administrator 
to defer initiating the action requested by the petitioner until such time 
as the court prescribes. 

(C) The court in issuing any final order in any action brought pur- 
suant to subparagraph (A) may award costs of suit and reasonable 
fees for attorneys and expert witnesses if the court determines that 
such an award is appropriate. Any court, in issuing its decision in an 
action brought to review such an order, may award costs of suit and 
reasonable fees for attorneys if the court determines that such an 
award is appropriate. 

(5) The remedies under this section shall be in addition to, and not 
in lieu of, other remedies provided by law. 



44 



90 STAT. 2044 



PUBLIC LAW 94-469— OCT. 11, 1976 



15 use 2621. 



Publication in 
Federal Register. 
Notice to 
congressional 
committee. 



15 use 2622. 



Notification. 

Investigation. 
Notification. 



Notice, hearing. 



SEC. 22. NATIONAL DEFENSE WAIVER. 

The Administrator shall waive compliance with any provision of 
this Act upon a request and determination by the President that the 
requested waiver is necessarjr in the interest of national defense. The 
Administrator shall maintain a written record of the basis upon 
which such waiver was granted and make such record available for in 
camera examination when relevant in a judicial proceeding under 
this Act. Upon the issuance of such a waiver, the Administrator shall 
publish in the Federal Register a notice that the waiver was granted 
for national defense purposes, unless, upon the request of the Presi- 
dent, the Administrator determines to omit such publication because 
the publication itself would be contrary to the interests of national 
defense, in which event the Administrator shall submit notice thereof 
to the Armed Services Committees of the Senate and the House of 
Representatives. 

SEC. 23. EMPLOYEE PROTECTION. 

(a) In General. — No employer may discharge any employee or 
otherwise discriminate against any employee with respect to the 
employee's compensation, terms, conditions, or privileges of employ- 
ment because the employee (or any person acting pursuant to a request 
of the employee) has — 

(1) commenced, caused to be commenced, or is about to com- 
mence or cause to be commenced a proceeding under this Act ; 

(2) testified or is about to testify in any such proo«eding; or 

(3) assisted or participated or is about to assist or participate 
in any manner in such a proceeding or in any other action to 
carry out the purposes of this Act. 

(b) Remedy. — (1) Any employee who believes that the employee 
has been discharged or otherwise discriminated against by any person 
in violation of subsection (a) of this section may, within 30 days after 
such alleged violation occurs, file (or have any person file on the 
employee's behalf) a complaint with the Secretary of Labor (here- 
inafter in this section referred to as the "Secretary") alleging such 
discharge or discrimination. Upon receipt of such a complaint, the 
Secretary shall notify the person named in the complaint of the filing 
of the complaint. 

(2) (A) Upon receipt of a complaint filed under paragraph (1), the 
Secretary shall conduct an investigation of the violation alleged in the 
complaint. Within 30 days of the receipt of such complaint, the Secre- 
tary shall complete such investigation and shall notify in writing the 
complainant (and any person acting on behalf of the complainant) 
and the person alleged to have committed such violation of the results 
of the investigation conducted pursuant to this paragraph. Within 
ninety days of the receipt of such complaint the Secretary shall, imless 
the proceeding on the complaint is terminated by the Secretary on the 
basis of a settlement entered into by the Secretary and the person 
alleged to have committed such violation, issue an order either pro- 
viding the relief prescribed by subparagraph (B) or denying the 
complaint. An order of the Secretary shall be made on the record after 
notice and opportunity for agency hearing. The Secretarv may not 
enter into a settlement terminating a proceeding on a complaint with- 
out the participation and consent of the complainant. 

(B) If in response to a complaint filed under paragraph (1) the 
Secretary determines that a violation of subsection (a) of this section 
has occurred, the Secretary shall order (i) the pei-son who committed 
such violation to take affirmative action to abate the violation, (ii) 



45 



PUBLIC LAW 94-469— OCT. 11, 1976 90 STAT. 

such person to reinstate the complainant to the complainant's former 
position together with the compensation (including back pay), terms, 
conditions, and privileges of the complainant's employment, (lii) com- 
pensatory damages, and (iv) where appropriate, exemplary damag;es. 
If such an order issued, the Secretary, at the request of the complain- 
ant, shall assess against the person against whom the order is issued a 
sum equal to the aggregate amount of all costs and expenses (including 
attorney's fees) reasonably incurred, as determined by the Secretary, 
by the complainant for, or in connection with, the bringing of the com- 
plaint upon which the order was issued. 

(c) Review. — (1) Any employee or employer adversely affected or 
aggrieved by an order issued under subsection (b) may obtain review 
of the order in the United States Court of Appeals for the circuit in 
which the violation, with respect to which the order was issued, 
allegedly occurred. The petition for review must be filed within sixty 
days from the issuance of the Secretar>''s order. Review shall conform 
to chapter 7 of title 5 of the United States Code. 

(2) An order of the Secretary, with respect to which review could 
have been obtained under paragraph (1), shall not be subject to 
judicial review in any criminal or other civil proceeding. 

(d) Enforcement. — Whenever a person has failed to comply with Gvil action, 
an order issued under subsection (b)(2), the Secretary shall file a civil 

action in the United States district court for the district in which the 
violation was found to occur to enforce such order. In actions brought Jurisdiction, 
under this subsection, the district courts shall have jurisdiction to 
grant all appropriate relief, including injunctive relief and compensa- 
tory and exemplary damages. Civil actions brought under this sub- 
section shall be heard and decided expeditiously. 

(e) Exclusion. — Subsection (a) of this section shall not apply with 
respect to any employee who, acting without direction from the 
employee's employer (or any agent of the employer), deliberately 
causes a violation of any requirement of this Act. 

SEC. 24. EMPLOYMENT EFFECTS. 

(a) In General. — ^The Administrator shall evaluate on a continuing Evaluation, 
basis the potential effects on employment (including reductions in 15 USC 2623 
employment or loss of employment from threatened plant closures) 

of — 

(1) the issuance of a rule or order under section 4, 5, or 6, or 

(2) a requirement of section 5 or 6. 

(b) (1) Investigations. — Any employee (or any representative of 
an employee) may request the Administrator to make an investigation 
of — 

(A) a discharge or layoff or threatened discharge or layoff of 
the employee, or 

(B) adverse or threatened adverse effects on the employee's 
employment, 

allegedly resulting from a rule or order under section 4, 5, or 6 or a 
requirement of section 5 or 6. Any such request shall be made in writ- 
ing, shall set foith with reasonable particularity the grounds for the 
request, and shall be signed by the employee, or representative of such 
employee, making the request. 

(2) (A) Upon receipt of a request made in accordance with para- Public hearings 
graph (1) the Administrator shall (i) conduct the investigation 
requested, and (ii) if requested by any interested person, hold public 
hearings on any matter involved in the investigation unless the Admin- 
istrator, by order issued within 45 days of the date such hearings are 



46 



90 STAT. 2046 



PUBLIC LAW 94-469~0CT. 11, 1976 



Notification. 



Publication in 
Federal Register. 



Recommenda- 
tions. 



15 use 2624. 



Submittal to 
Congress. 
GAO review. 



Consultation. 



Report to 
Congress. 



15 use 2625. 



requested, denies the request for the hearings because the Adminis- 
trator determines there are no reasonable grounds for holding such 
hearings. If the Administrator makes such a determination, the 
Administrator shall notify in writing the person requesting the hear- 
ing of the determination and the reasons therefor and shall publish the 
determination and the reasons therefor in the Federal Register. 

(B) If public hearings are to be held on any matter involved in an 
investigation conducted under this subsection — 

(i) at least five days' notice shall be provided the person mak- 
ing the request for the investigation and any person identified in 
such request, 

(ii) such hearings shall be held in accordance with section 
6(c) (3), and 

(iii) each employee who made or for whom was made a request 
for such hearings and the employer of such employee shall be 
required to present information respecting the applicable matter 
referred to in paragraph (1)(A) or (1) (B) together with the 
basis for such information. 

(3) Upon completion of an investigation under paragraph (2), the 
Administrator shall make findings of fact, shall make such recom- 
mendations as the Administrator deems appropriate, and shall make 
available to the public such findings and recommendations. 

(4) This section shall not be construed to require the Administrator 
to amend or repeal any rule or order in effect under this Act. 

SEC. 25. STUDIES. 

(a) Indemnification Study.— The Administrator shall conduct a 
study of all Federal laws administered by the Administrator for the 
purpose of determining whether and unaer what conditions, if any, 
indemnification should be accorded any person as a result of any action 
taken by the Administrator under any such law. The studjr shall — 

(1) include an estimate of the probable cost of anymdemnifica- 
tion programs which may be recommended ; 

(2) include an examination of all viable means of financing the 
cost of any recommended indemnification ; and 

(3) be completed and submitted to Congress within two years 
from the effective date of enactment of this Act. 

The General Accounting Office shall review the adequacy of the study 
submitted to Congress pursuant to paragraph (3) and shall report the 
results of its review to the Congress within six months of the date 
such study is submitted to Congress. 

(b) Classification, Storage, and Retrieval Study. — The Council 
on Environmental Quality, in consultation with the Administrator, 
the Secretary of Health, Education, and Welfare, the Secretary of 
Commerce, and the heads of other appropriate Federal departments or 
agencies, shall coordinate a study of the feasibility of establishing (1) 
a standard classification system for chemical substances and related 
substances, and (2) a standard means for storing and for obtaining 
rapid access to information respecting such substances. A report on 
such study shall be completed and submitted to Congress not later than 
18 months after the effective date of enactment of this Act. 

SEC. 26. ADMINISTRATION OF THE ACT. 

(a) Cooperation of Federal Agencies. — Upon request by the 
Administrator, each Federal department and agency is authorized — 
(1) to make its services, personnel, and facilities available 
(with or without reimbursement) to the Administrator to assist 
the Administrator in the administration of this Act; and 



47 



PUBLIC LAW 94-469— OCT. 11, 1976 90 STAT. 2047 

(2) to furnish to the Administrator such information, data, 
estimates, and statistics, and to allow the Administrator access to 
all information in its possession as the Administrator may reason- 
ably determine to be necessary for the administration of this Act. 

(b) Fees. — (1) The Administrator may, by rule, require the pay- 
ment of a reasonable fee from any person required to submit data 
under section 4 or 5 to defray the cost of administering this Act. Such 
rules shall not provide for any fee in excess of $2,500 or, in the case of 
a small business concern, any fee in excess of $100. In setting a fee 
under this paragraph, the Administrator shall take into account the 
ability to pay of the person required to submit the data and the cost 
to the Administrator of reviewing such data. Such rules may provide 
for sharing such a fee in any case in which the expenses of testing are 
shared under section 4 or 5. - 

(2) The Administrator, after consultation with the Administrator Consultation, 
of the Small Business Administration, shall by rule prescribe stand- ^^f^- 
ards for determining the persons which qualify as small business 
concerns for purposes of paragraph (1). 

(c) Action With Respect to Categories. — (1) Any action author- 
ized or required to be taken by the Administrator under any provision 
of this Act with respect to a chemical substance or mixture may be 
taken by the Administrator in accordance with that provision with 
respect to a category of chemical substances or mixtures. Whenever 
the Administrator takes action under a provision of this Act with 
respect to a category of chemical substances or mixtures, any reference 
in this Act to a chemical substance or mixture (insofar as it relates 
to such action) shall be deemed to be a reference to each chemical 
substance or mixture in such category. 

(2) For purposes of paragraph ( 1 ) : Definitions. 

(A) The term "category of chemical substances" means a group 
of chemical substances the members of which are similar in molec- 
ular structure, in physical, chemical, or biological properties, in 
use, or in mode of entrance into the human body or into the 
environment, or the members of which are in some other way suit- 
able for classification as such for purposes of this Act, except that 
such term dees not mean a group of chemical substances which are 
grouped together solely on the basis of their being new chemical 
substances. 

(B) The term "category of mixtures" means a group of mix- 
tures the members of which are similar in molecular structure, in 
physical, chemical, or biological properties, in use, or in the mode 
of entrance into the human body or into the environment, or the 
members of which are in some other way suitable for classification 
as such for purposes of this Act. 

(d) Assistance Office. — The Administrator shall establish in the Establishment. 
Environmental Protection Agency an identifiable office to provide 
technical and other nonfinancial assistance to manufacturers and 
processors of chemical substances and mixtures respecting the require- 
ments of this Act applicable to such manufacturei^ and processors, the 

policy of the Agency respecting the application of such requirements 
to such manufacturers and processors, and the means and methods by 
which such manufacturers and processors may comply with such 
requirements. 

(e) Financial Disclosures. — (1) Except as provided under para- , 
graph (3), each officer or employee of the Environmental Protection 
Agency and the Department of Health, Education, and Welfare who — 

(A) performs any function or duty under this Act, and 



\ 



48 



90 STAT^2048 PUBLIC LAW 94-469— OCT. 11, 1976 

(B) has any known financial interest (i) in any person subject 
to this Act or any rule or order in effect under this Act, or (ii) in 
any person who applies for or receives any grant or contract under 
this Act, 

shall, on February 1, 1978, and on February 1 of each year thereafter, 
file with the Administrator or the Secretary of Health, Education, and 
Welfare (hereinafter in this subsection referred to as the "Secre- 
tary") , as appropriate, a written statement concerning all such inter- 
ests held by such officer or employee during the preceding calendar 
year. Such statement shall be made available to the public. 

(2) The Administrator and the Secretai-y shall — 

(A) act within 90 days of the effective date of this Act — 

(i) to define the term "known financial interests" for pur- 
poses of paragraph ( 1) , and 

(ii) to establish the methods by which the requirement to 
file written statements specified in paragraph (1) will be 
monitored and enforced, including appropriate provisions for 
review by the Administrator and the Secretary of such state- 
ments; and 

Report to (B) report to the Congress on June 1, 1978, and on June 1 of 

Congress. e&ch. year thereafter with respect to such statements and the 

actions taken in regard thereto during the preceding calendar 

year. 

(3) The Administrator may by rule identify specific positions with 
the Environmental Protection Agency, and the Secretary may by rule 
identify specific positions with the Department of Health, Education, 
and Welfare, which are of a nonregulatory or nonpolicymaking 
nature, and the Administrator and the Secretary may by rule provide 
that officers or employees occupying such positions shall be exempt 
from the requirements of paragraph (1). 

(4) This subsection does not supersede any requirement of chapter 
11 of title 18, United States Code. 

Penalty. (5) Any officer or employee who is subject to, and knowingly vio- 

lates, this subsection or any rule issued thereunder, shall be fined not 
more than $2,500 or imprisoned not more than one year, or both. 

(f) Statement of Basis and Purpose. — Any final order issued 
under this Act shall be accompanied by a statement of its basis and 
purpose. The contents and adequacy of any such statement shall not 
be subject to judicial review in any respect. 

Appointment. (g) ASSISTANT ADMINISTRATOR. — (1) The President, by and witli 

the advice and consent of the Senate, shall appoint an Assistant 
Administrator for Toxic Substances of the Environmental Protection 
Agency. Such Assistant Administrator shall be a qualified individual 
who is, by reason of background and experience, especially qualified 
to direct a program concerning the effects of chemicals on human 
health and the environment. Such Assistant Administrator shall be 
responsible for (A) the collection of data, (B) the preparation of 
studies, (C) the making of recommendations to the Administrator for 
regulatory and other actions to carry out the purposes and to facili- 
tate the administration of this Act, and (D) such other functions as 
the Administrator may assign or delegate. 

(2) The Assistant Administrator to be appointed under paragraph 
(1) shall (A) be in addition to the Assistant Administrators of the 
Environmental Protection Agency authorized by section 1(d) of Reor- 

5 use app. II. ganization Plan No. 3 of 1970, and (B) be compensated at the rate of 
pay authorized for such Assistant Administrators. 



49 



PUBLIC LAW 94-469— OCT. 11, 1976 



90 STAT. 2049 



EC. 27. DEVELOPMENT AND EVALUATION OF TEST METHODS. 

(a) In Gener.\l. — The Secretary of Health, Education, and Welfare, 
n consultation with the Administrator and acting through the Assist- 
nt Secretary for Health, may conduct, and make grants to public and 
onprofit private entities and enter into contracts with public and 
•rivate entities for, projects for the development and evaluation of 
nexpensive and efficient methods (1) for determining and evaluating 
he healtli and environmental effects of chemical substances and mix- 
ures, and their toxicity, persistence, and other characteristics which 
ffect health and the environment, and (2) which may be used for the 
development of tost data to meet the requirements of rules promulgated 
nder section 4. The Administrator shall consider such methods in 
>rescribing under section 4 standards for the development of test data. 

(b) Approval by Secretary. — No grant may be made or contract 
ntered into under subsection (a) unless an application therefor has 
•een submitted to and approved by the Secretary. Such an application 
hall be submitted in such form and manner and contain such informa- 
ion as the Secretary may require. The Secretary may apply such 
onditions to grants and contracts under subsection (a) as the Secre- 
ary determines are necessary to carry out the purposes of such subsec- 
ion. Contracts may be entered into under such subsection without 
egard to sections 3648 and 3709 of the Revised Statutes (31 U.S.C. 
'39; 41 U.S.C. 5). 

(c) Annual Reports. — (1) The Secretary shall prepare and sub- 
ait to the President and the Congress on or before January 1 of each 
'ear a report of the number of grants made and contracts entered into 
mder this section and the results of such grants and contracts. 

(2) The Secretary shall periodically publish in the Federal Register 
eports describing the progress and results of any contract entered 
nto or grant made under this section. 
>EC. 28. STATE PROGRAMS. 

(a) In General. — For the purpose of complementing (but not reduc- 
ng) the authority of, or actions taken by, the Admmistrator under 
his Act, the Administrator may make grants to States for the estab- 
ishment and operation of programs to prevent or eliminate unreason- 
ble risks within the States to health or the environment which are asso- 
iated with a chemical substance or mixture and with respect to which 
he Administrator is unable or is not likely to take action under this 
Let for their prevention or elimination. The amount of a grant under 
his subsection shall be determined by the Administrator, except that 
lo grant for any State program may exceed 75 per centum of the 
istablishment and operation costs (as determined by the Admin- 
strator) of such program during the period for which the grant is 
Qade. 

(b) Approval by Administrator. — (1) No grant may be made under 
ubsection (a) unless an application therefor is submitted to and 
approved by the Administrator. Such an application shall be sub- 
nitted in such form and manner as the Administrator may require and 
ihall— 

(A) set forth the need of the applicant for a grant under subsec- 
tion (a), 

(B) identify the agency or agencies of the State which shall 
establish or operate, or both, the program for which the applica- 
tion is submitted, 

(C) describe the actions proposed to be taken under such pro- 
gram, 



G>nsultation. 
15 use 2626. 



Grants or 
contracts, 
application. 



Report to 
President and 
G)ngress. 

Publication in 
Federal Register. 



15 use 2627. 



Grants, 
application. 



50 



90 STAT. 2050 PUBLIC LAW 94-469— OCT. 11, 1976 

(D) contain or be supported by assurances satisfactory to the 
Administrator that such program shall, to the extent feasible, 
be integrated with other programs of the applicant for environ- 
mental and public health protection, 

(E) provide for the making of such reports and evaluations 
as the Administrator may require, and 

(F) contain such other information as the Administrator may 
prescribe. 

Application (2) The Administrator may approve an application submitted in 

approval. accordance with paragraph (1) only if the applicant has established to 

the satisfaction of the Administrator a priority need, as determined 
under rules of the Administrator, for the grant for which the appli- 
cation has been submitted. Such rules shall take into consideration the 
seriousness of the health effects in a State which are associated with 
chemical substances or mixtures, including cancer, birth defects, and 
gene mutations, the extent of the exposure in a State of human beings 
and the environment to chemical substances and mixtures, and the 
extent to which chemical substances and mixtures are manufactured, 
processed, used, and disposed of in a State. 
Report to (c) Annual Reports. — Not later than six months after the end of 

Congress. each of the fiscal years 1979, 1980, and 1981, the Administrator shall 

submit to the Congress a report respecting the programs assisted by 
grants under subsection (a) in the preceding fiscal year and the extent 
to which the Administrator has disseminated information respecting 
such programs. 

(d) Authorization. — For the purpose of making grants under 
subsection (a) there are authorized to be appropriated $1,500,000 for 
the fiscal year ending September 30, 1977, $1,500,000 for the fiscal year 
ending September 30, 1978, and $1,500,000 for the fiscal year ending 
September 30, 1979. Sums appropriated under this subsection shall 
remain available until expended. 
SEC. 29. AUTHORIZATION FOR APPROPRIATIONS. 
15 use 2628. There are authorized to be appropriated to the Administrator for 

purposes of carrying out this Act (other than sections 27 and 28 and 
subsections (a) and (c) through (g) of section 10 thereof) $10,100,000 
for the fiscal year ending September 30, 1977, $12,625,000 for the fiscal 
year ending September 30, 1978, $16,200,000 for the fiscal year ending 
September 30, 1979. No part of the funds appropriated under this 
section may be used to construct any research laboratories. 
SEC. 30. ANNUAL REPORT. 
Report to The Administrator shall prepare and submit to the President and 

President and ^j^^ Congress on or before January 1, 1978, and on or before January 1 
?iisr*9fi5>Q ^^^^ succeeding year a comprehensive report on the administration 

5 UbL 2629. ^^^-^ during the preceding fiscal year. Such report shall include — 

(1) a list of the testing required under section 4 during the year 
for which the report is made and an estimate of the costs incurred 
during such year by the persons required to perform such tests; 

(2) the number of notices received during such year under 
section 5, the number of such notices received during such year 
under such section for chemical substances subject to a section 4 
rule, and a summary of any action taken during such year under 
section 5(g); 

(3) a list of rules issued during such year under section 6 ; 

(4) a list, with a brief statement of the issues, of completed or 
pending judicial actions under this Act and administrative actions 
under section 16 during such year ; 



51 



PUBLIC LAW 94^9— OCT. 11, 1976 90 STAT. 2051 

(5) a summary of major problems encountered in the adminis- 
tration of this Act ; and 

(6) such recommendations for additional legislation as the Recommenda- 
Administrator deems necessary to carry out the purposes of this 

Act. 

SEC 31. EFFECTIVE DATE. 

Eixcept as provided in section 4(f), this Act shall take effect on 15 USC 2601 
January 1, 1977. °ote. 

Approved October 11, 1976. 



LEGISLATIVE HISTORY : 

HOUSE REPORTS: No. 94-1341 accompanying H.R. 14032 (Comm. on Interstate and 

Foreign Commerce) and No. 94-1679 (Comm. of Conference). 
SENATE REPORTS: No. 94-698 (Comm. on Commerce) and No. 94-1302 (Comm. of 

Conference). 
CONGRESSIONAL RECORD, Vol. 122 (1976): 
Mar. 26, considered and passed Senate. 

Aug. 23, considered and passed House, amended, in lieu of H.R. 14032. 
Sept. 28, Senate and House agreed to conference report. 
WEEKLY COMPILATION OF PRESIDENTIAL DOCUMENTS, Vol. 12, No. 42: 
Oct. 12, Presidential statement. 



Note. — A change has been made in the slip law format to provide for one-time 
preparation of copy to be used for publication of both slip laws and the United 
States Statutes at Large volumes. Comments from users are invited by the Office of 
the Federal Register, National Archives and Records Service, Washington, D.C. 
20408. 



(Excerpt from Weekly Compilation of Presidential Documents, vol. 12, No. 42. Oct. 18, 

1976, p. 1489] 

Statement of the President on Signing S. 3149 Into Law — 

October 12, 1976 

I have signed S. 3149, the Toxic Substances Control Act. I believe 
this legislation may be one of the most important pieces of environ- 
mental legislation that has been enacted by the Congress. 

This toxic substances control legislation provides broad authority to 
regulate any of the tens of thousands of chemicals in commerce. Only 
a few of these chemicals have been tested for their long-term effects on 
human health or the environment. Through the testing and reporting 
requirements of the law% our understanding of these chemicals should 
be greatly enhanced. If a chemical is found to present a danger to 
health or the environment, appropriate regulatory action can be taken 
before it is too late to undo the damage. 

The legislation provides that the Federal Government through the 
Environmental Protection Agency may require the testing of selected 
new chemicals prior to their production to determine if they will pose 
a risk to health or the environment. Manufacturers of all selected new 
chemicals w411 be required to notify the Agency at least 90 days before 
commencing commercial production. The Agency may promulgate 
regulations or go into couit to restrict the production or use of a chem- 
ical or to even ban it if such drastic action is necessary. 

The bill closes a gap in our current array of laws to protect the 
health of our people and the environment. The Clean Air Act and the 
Water Pollution Control Act protect the air and water from toxic 
contaminants. The Food and Drug Act and the Safe Drinking Water 
Act are used to protect the food we eat and the water we drink against 
hazardous contaminants. Other provisions of existing laws protect 
the health and the environment against other polluting contaminants 
such as pesticides and radiation. However, none of the existing stat- 
utes provide comprehensive protection. 

This bill provides broad discretionary authority to protect the health 
and environment. It is critical, however, that the legislation be admin- 
istered in a manner so as not to duplicate existing regulatory and en- 
forcement authorities. 

In addition, I am certain that the Environmental Protection Agency 
realizes that it must carefully exercise its discretionary authority so 
as to minimize the regulatory burden consistent with the effective pro- 
tection of the health and environment. 

The administration, the majority and minority members of the 
Congress, the chemical industry, labor, consumer, environmental, and 
other groups all have contributed to the bill as it has finally been 
enacted. It is a strong bill and will be administered in a way which 
focuses on the most critical environmental problems not covered by 
existing legislation while not overburdening either the regulatory 
agency, the regulated industry, or the American people. 



(53) 



CHAPTER II 



S. 3149 TOGETHER WITH REPORT AND DEBATE 

Note. — S. 3149 was introduced as a clean bill: the original bill on which 
hearings were held was S. 776. 



57 



94Tn CONGUESS 
2d Session 



Calendar No. 668 

S. 3149 

[Report No. 94-698] 



IN THE SENATE OF THE UNITED STATES 

March 16, 1976 

Mr. TuNNEY (for himself and Mr. IIartke) introduced the following bill; 
which was read twice and referred to the Committee on Commerce 

March 16,1976 
Reported by Mr. Tunxev, without amendment 



A BILL 

To regulate commerce and protect human health and the envh-on- 
ment by requiring testing and necessary use restrictions on 
certain chemical substances, and for other purposes. 

1 Be it enacted by the Senate and House of Representa- 

2 tives of the United States of America in Congress assembled, 

3 SIIOET TITLE AND TABLE OF CONTENTS 

4 Section 1. This Act may be cited as the ''Toxic Sub- 

5 stances Control Act". 

TABLE OF CONTENTS 

Sec. 1. Short title and table of contents. 

Sec. 2. Findings, policy, and intent. 

Sec. 3. Definitions and exclusions. 

Sec. 4. Testing of chemical substances and mixtures. 

Sec. 5. Premarket notification of chemical substances. 

Sec. 6. Regulation of chemical substances and mixtures. 

Sec. 7. Imminent hazards. 

Sec. 8. Reporting and retention of information. 

II 



58 



2 



TABLE OF CONTENTS— Continued 



Sec. 


9. Relationship to other Federal laws. 


Sec. 


10. 


Research, collection, dissemination, and utilization of data. 


Sec. 


11. 


Inspections. 


Sec. 


12. 


Exports. 


Sec. 


13. 


Entry into customs territory of the United States. 


Sec. 


14. 


Disclosure of data. 


Sec. 


15. 


Prohibited acts. 


Sec. 


16. 


Penalties. 


Sec. 


17. 


Specific enforcement and seizure. 


Sec. 


18. 


Preemption. 


Sec. 


19. 


Judicial review. 


Sec. 


20. 


Citizen's civil action. 


Sec. 


21. 


Citizen's petitions. 


Sec. 


22. 


National defense waiver. 


Sec. 


23. 


Employee protection. 


Sec. 


24. 


Studies. 


Sec. 


25. 


Administration of Act. 


Sec. 


26. 


Authorization for appropriations. 


Sec. 


27. 


Aimual report. 



1 FINDINGS, POLICY, AND INTENT 

2 Sec. 2. (a) Findings— The Congress finds that— 

3 ( 1 ) humans and the environment are being ex- 

4 posed to a large number of chemical substances and 

5 mixtures each year; 

6 (2) among the many chemical substances and mix- 

7 tures constantly being developed and produced are some 

8 whose manufacture, processing, distribution in com- 

9 merce, use, or disposal may cause or contribute to an 

10 unreasonable risk of injury to health or the environ- 

11 ment; and 

12 (o) the effective regulation of such chemical sub- 

13 - stances and mixtures in interstate commerce necessitates 
■^^ the regulation of such chemical substances and mixtures 

in intrastate commerce as well. 



59 



3 

1 (b) Policy.— It is the policy of the United States 

2 that— 

3 (1) adequate data should be developed with re- 

4 spect to chemical substances and mixtures concerning 

5 their effect on human health and the environment and 

6 that such data development should be die responsibil- 

7 ity of those who manufacture and those who process 

8 such chemical substances and mixtures ; 

9 (2) adequate authority should exist to regulate 

10 chemical substances and mixtures which cause or con- 

11 tribute to an unreasonable risk of injury to health or the 

12 environment, and to take action with respect to chemical 

13 substances and mixtures Avhich are imminent hazards; 

14 and 

15 (3) authority over chemical substances and mix- 

16 tures should be exercised m such a manner as not to 

17 impede unduly or create unnecessary economic barriers 

18 to technological innovation while fulfilling the primary 

19 purpose of tliis Act to ass,ure that such innovation and 

20 commerce in such chemical substances and mixtures do 

21 not cause or contribute <to an unreasonable risk of injury 

22 to health or the environment. 

23 (c) Intent of Congress.— It is the intent of Con- 

24 gross that the Administrator shall carry out this Act in a 

25 reasonable and prudent manner, and that the Administrator 



60 



4 

1 stall consider the environmental, economic, and social impact 

2 of any action the Administrator takes or proposes to take 

3 under this Act. 

4 DEFINITIONS AND EXCLUSIONS 

5 Sec. 3. (a) Definitions— As used in this Act: 

6 (1) The term ''Administrator" means the Administra- 

7 tor of the Environmental Protection Agency. 

8 (2) (A) Except as provided in suhparagraph (B), the 

9 term "chemical substance" means — 

10 (i) any organic or inorganic substance of a par- 

11 ticular molecular identity including a combination of 

12 such substances occ.urring as a result of a chemical 

13 reaction, or 

14 (ii) any element or uncombined radical. 

15 (B) Such term does not include — 

16 (i) any mixture, 

17 (ii) any pesticide (as defined in the Federal In- 

18 secticide. Fungicide and Rodenticide Act) when manu- 

19 factured or distributed in commerce for use as a pesti- 

20 cide, 

21 (iii) tobacco or any tobacco product, 

22 (iv) any source material, special nuclear material, 

23 or byproduct material (as such terms are defined in the 

24 Atomic Energy Act of 1954 and regulations issued under 

25 such Act) , 



61 



5 

1 (v) any article which, if sold by the manufacturer, 

2 would be subject to the tax imposed by section 4181 of 

3 the Internal Revenue Code of 1^54 (determined without 

4 regard to any exemptions from such tax provided by sec- 

5 tion 4182 or 4221 or any other provision of such Code) , 

6 and 

7 (vi) any substance found in or on any food, or 

8 any drug, cosmetic, or device (as such terms are de- 

9 fined in section 201 of the Federal Food, Drug, and 

10 Cosmetic Act) when (A) manufactured or distributed 

11 in commerce for use in or on any such food, or as any 

12 such drug, cosmetic, or device, or (B) produced for 

13 research and development purposes and intended only 

14 for use in or on any such food, or as any such drug, 

15 cosmetic, or device. 

16 The term ''food" as used in clause (vi) of this subparagraph 

17 includes poultry and poultry products (as defined m sections 

18 4 {e) and 4(f) of the Poultry Products Inspection Act), 

19 meat and meat food products (as defined in section 1 (j) of 

20 the Federal Meat Inspection Act) , and eggs and egg prod- 

21 ucts (as defined in section 4 of the Egg Products Inspection 

22 Act). 

23 (3) The term ''commerce" means trade, traffic, or trans- 

24 portation (A) between a place in a State and any place 



62 



6 

1 outside of such State, or (B) which affects such trade, 

2 traffic, or transportation. 

3 (4) The term ''distribute in commerce" or "distribu- 

4 tion in commerce" when used to describe an action taken 

5 with respect to a chemical substance or mixture means to 

6 sell, or the sale of, the substance or mixture; to introduce or 

7 deliver for introduction into commerce, or the introduction or 

8 delivery for introduction into commerce of, the substance or 

9 mixture; or to hold, or the holding of, the substance or 

10 mixture after its introduction into conmierce. 

11 (5) The term "environment" includes humans and 

12 their environment, water, atmosphere, and land and the 

13 interrelationships which exist among and between these. 

11 (6) The term ''health and safety study" means any 
study of any effects of a chemical substance or mixture on 

1^ health or the environment, including epidemiological studies, 

1' studies of occupational exposure to a chemical substance bt 
mixture, toxicological, clinical, and ecological studies of a 

1^ chemical sul^stance or mixture, and any test perforaicd pur- 

-0 suant to this Act. 

^1 (7) The term "manufacture" means to import, produce, 

or manufacture for commercial purposes. 

(8) The term "mixture" means any combination of two 
^4 or more clieniicnl substances if such su))stances (A) do not 



63 



7 

1 react chemically with each other and if the combination is not 

2 the result of a chemical reaction, or (B) occur in nature. 

3 (9) The term ''new chemical substance" means any 

4 chemical substance not included in the chemical substance 

5 hst compiled and published under section 8 (b) . 

6 (10) The term ''process" means the preparation of a 

7 chemical subsUuice or mixture for distribution in commerce — 

8 (A) in the same form or physical state, or in a 

9 different form or physical state from that m which it 

10 was received by the person making such preparation, or 

11 (B) as part of an article containing the chemical 

12 substimce or mixture. 

13 (11) The tei-m "processor" means any person who 

14 processes a chemical substance or mixture. 

IT) (12) The temi "standards for the development of test 
datii" means a prescription of — 

17 . (A) the— 

18 (i) health and environmental effects, and 

19 (ii) ty]3e of information relating to toxicity, 

20 persistence, and other characteristics w'hich relate to 

21 effects on health and the environment 

22 for which test data for a chemical substance or mixture 

23 are to be developed and any analysis that is to be per- 

24 fonned on such data, and 



64 



8 

1 (B) to the extent necessary to assure that such data 

2 are reliable and adequate, the manner in w*hich such 

3 data are to be developed, the specification of any test 

4 protocol or methodology to be employed in the develop- 

5 ment of data respecting such effects and characteristics, 
Q and such other requirements as are necessary to provide 

7 such assurance. 

8 (13) The term ^'State" means any of^the several 

9 States, the District of Columbia, the Commonwealth of 

10 Puerto Eico, the Virgin Islands, Guam, the Canal Zone, 

11 American Samoa, or the Trust Territory of the Pacific 

12 Islands. 

13 (14) The term "United States", when used in the 

14 geogi'aphic sense, means all the States. 

15 (b) Exclusions.— The Administrator may exclude 

16 from coverage of this Act or any provision of this Act any 

17 chemical substance or mixture if the Administrator deter- 

18 mines, by rule, that such substance or mixture does not 

19 present an unreasonable risk of injury to health or the 

20 environment, except that any such exclusion shall not apply 

21 to section 7 or 8(e). Any such rule shall (A) be pro- 

22 mulgated pursuant to the procedures specified in section 

23 6(c) (2), (3), (4), and (5) and (B) may be modified, 

24 amended, or revoked in accordance with the requirements 



65 



9 

1 of this subsection and pursuant to the procedures specified 

2 in such section 6(c) (2), (3), (4), and (5). 

3 TESTING OF CHEMICAL SUBSTANCES AND MIXTURES 

4 Sec. 4. (a) Testing Eequirements .— If the Ad- 

5 ministrator finds that — 

6 (1) (A) (i) the manufacture, processing, distribu- 

7 tion in commerce, use, or disposal of a chemical sub- 

8 stance or mixture may present an unreasonable risk of 

9 injury to health or the environment, or (ii) (I) that the 

10 manufacture, processing, distribution in commerce, use, 

11 or disposal of a chemical substance or mixture may 

12 present significant human or environmental exposure 

13 because it is or will be produced in substantial quantities 

14 or for other reasons, and (II) that such substance or 

15 mixture may perhaps present an adverse effect on health 

16 or the environment, 

17 " (^) there are insufficient data or experience upon 

18 which the effects of such manufacture, processing, dis- 

19 tribution in commerce, use, or disposal on health or 

20 the environment can reasonably be determined or pre- 

21 dieted, and 

22 (C) testing of such substance or mixture with 

23 respect to such effects is necessary to develop such data ; 

24 and 



66 



10 

1 (2) in the case of a mixture, the effects which the 

2 mixture's manufacture, distribution in commerce, proc- 

3 essing, use, or disposal may have on health or the en- 

4 vironment may not be reasonably and more eflSciently 

5 determined or predicted by testing the chemical sub- 

6 stances which comprise the mixture ; 

7 the Administrator shall by rule require that testing be con- 

8 ducted on such substance or mixture to develop data with 

9 respect to the health and environmental effects for which 

10 there is an insuffidency of data or experience and which 

11 are relevant to a determination that the manufacture, distri- 

12 bution in commerce, processing, use, or disposal of such 

13 substance or mixture does or does not cause or contribute to 

14 an unreasonable risk of injuiy to health or the environment. 

15 In requiring tests under this subsection, the Administrator 

16 shall consider the reasonably ascertainable costs and other 

17 burdens associated with conducting such tests in light of the 

18 possible risks of injury to health or the environment and shall 
IP publish the same in the Federal Register. The finding in 

20 paragraph (1) (A) (ii) (II) shall be presumed if the Ad- 

21 ministrator has no reliable data or experience available to 

22 him concerning the chemical substance or mixture. The find- 

23 ing in paragraph (1) (A) (ii) (11) shall not be subject to 

24 judicial review on any ground other than the fact that such 

25 finding was not made. 



67 



11 

1 (b) (1) Testing Requirement Eule— A rule under 

2 subsection (a) requiring the testing of a chemical substance 

3 or mixture shall include — 

4 (A) identification of the substance or mixture for 

5 which testing is required, 

6 (B) standards for the development of test data for 

7 such substance or mixture, and 

8 (C) with respect to chemical substances which are 

9 not new chemical substances a specification of the period 

10 (which period may not be of unreasonable duration) 

11 within which the persons required to conduct the testing 

12 shall submit to the Administrator data developed in 

13 accordance with the standards referred to in subpara- 

14 graph (B) . 

15 Such a nile may require the submission of prehminary data 

16 during the period prescribed under subparagraph (C). 

17 (2)" (A) The health and environmental effects for which 

18 standards for tlie development of test data may be pre- 

19 scribed include carcinogenesis, mutagenesis, teratogenesis, 

20 behavioral disorders, cumulative or synergistic effects, and 

21 any other effect which may cause or contribute to an unrea- 

22 sonable risk of injury to health or the environment, and the 

23 characteristics of chemical substances and mixtures for which 

24 such standards may be prescribed include persistence, acute 

25 toxicity, subacute toxicity, chronic toxicity, and any other 



68 



12 

1 characteristic whicli may cause or contribute to such a risk 

2 of injury. The methodologies that may be prescribed in such 

3 standards include epidemiology, serial, or hierarchical tests; 

4 in vitro tests; and whole animal tests. 

5 (B) From time to time, but not less than once each 
ft' 

6 12 months, the Administrator shall review the adequacy 

7 of the standards for development of data prescribed in rules 

8 under subsection (a) and shall, if necessary, institute pro- 

9 ceedings to make appropriate revisions of such standards. 

10 (3) (A) A rule under subsection (a) respecting a 

11 chemical substance or mixture shall require the persons 

12 described in subparagraph (B) to conduct tests and submit 

13 data on such substance or mixture, except that the Admin- 

14 istrator may permit t^vo or more of such persons to designate 

15 one such person or a qualified third party to conduct such 

16 tests and submit such data on behaK of the persons making 

17 the designation. 

18 (B) The following persons shall be required to conduct 

19 tests and submit data on a chemical substance or mixture 

20 subject to a rule under subsection (a) : 

21 (i) Each person who manufactures or intends to 

22 manufacture such substance or mixture if the Adminis- 

23 trator made a finding described in subsection (a) (1) 

24 (B) with respect to the manufacture of the substance 



69 



13 

1 or mixture which such person is engaged in or intends 

2 to engage in. 

3 (ii) Each person who processes or intends to process 

4 such substance or mixture if the Administrator made a 

5 finding described in subsection (a) (1) (B) with respect 

6 to the processing of the substance which such person 

7 is engaged in or intends to engage in. 

8 (iii) Each person who manufactures or processes or 

9 intends to manufacture or process such substance or mix- 

10 tui'e if, with respect to the distribution in commerce, dis- 

11 posal or use of such substance or mixture manufactured 

12 or processed or to be manufactured or processed by such 

13 person, the Administrator made a finding described in 

14 subsection (a) (1) (B). 

15 (4) Rules issued under subsection (a) (and any amend- 

16 ment thereto or repeal thereof) shall be promulgated pur- 

17 suant to section 553 of title 5, United States Code, except 

18 that in promulgating, amending, or repealing any such rule 

19 (A) the Administrator shall give interested persons an op- 

20 portunity for the oral presentation of data, views, or argu- 

21 ments, in addition to an opportunity to make written sub- 

22 missions; and (B) a transcript shall be made of any oral 

23 presentation. 

24 (c) Exemption. — (1) Any person required by a rule 



70 



14 

1 under subsection (a) to conduct tests and submit data on a 

2 chemical substance or mixture may apply to the Adminis- 

3 trator (in such form and manner as the Administrator shall 

4 prescribe) for an exemption from such requuement. 

5 (2) If, upon receipt of an application under paragraph 

6 ( 1 ) , the Administrator determines that — 

7 (A) the chemical substance or mixture with respect 

8 to which such application was submitted is equivalent 

9 to a chemical substance or mixtm'e for which data has 

10 been submitted to the Administrator in accordance with 

11 a rule under subsection (a) or for which data is being 

12 developed pursuant to such a rule, and 

13 (B) submission of data by the applicant on such 

14 substance or mixture would be duplicative of data which 

15 has been submitted to the Administrator in accordance 

16 with such rule or which is being developed pursuant to 

17 such rule, 

18 the Administrator shall exempt, in accordance with para- 

19 graph (3) or (4), the apphcant from conducting tests and 

20 submitting data on such substance or mixture. 

21 (3) (A) If the exemption of any person from the re- 

22 quirement to conduct tests and submit test data on a chemical 

23 substance or mixture is granted on the basis of the existenee 

24 of previously submitted tesit data and if such exemption is 



71 

15 

1 granted d,uring the reimbursement period for such te&i data 

2 (as prescribed by subparagraph (B)), then (miless such 

3 person and the persons referred to in clauses (i) and (ii) 

4 agree on the amount and method of reimbursement) the 

5 Administrator shall order the person granted the exemption 

6 to provide fair and equitable reimbursement (in an amount 

7 determined under rules of the Administrator) — 

8 (i) to the person who previously submitted such test 

9 data, for a portion of the costs incui'red by such person 

10 in complying with the requirement to submit such data, 

11 and 

12 (ii) to any other person who has been required 

13 under this subparagraph to contribute with respect to 

14 such costs, for a portion of the amount such person was 

15 required to contribute. 

16 In promulgating rules for the detemiination of fair and 

17 equitable reimbursement to the persons described in clauses 

18 (i) and (ii) for costs incurred with respect to a chemical 

19 substance or mixture, the Administrator shall, after consul- 

20 tation with the Attorney General and the Federal Trade 

21 Commission, consider all relevant factors, including the 

22 effect on competition within the chemical industiy and the 

23 share of the market for such substance or mixture of the 

24 person required to provide reimbursement in relation to the 



72 



16 

1 share of such market of the persons to be reimbursed. An 

2 order under this subparagraph for purposes of judicial 

3 review shall be considered final agency action. 

4 (B) For purposes of subparagraph (A) , the reimburse- 

5 ment period for any test data for a chemical substance or 
Q mixture is a period — 

7 (i) beginning on the date such data was submitted 

g in accordance with a rule promulgated under subsection 

9 (a) , and 

10 (ii) ending— 

11 (I) two years after the date referred to in 

12 clause (i) , or 

13 (II) at the expiration of a period which begins 

14 on the date referred to in clause (i) and is equal to 

15 the period which the Administrator determines was 

16 necessary to develop such data, 

17 whichever is later. 

13 (4) (A) If the exemption of any person from the re- 



19 quirement to conduct tests and submit test data on a chemical 

20 substance or mixture is granted on the basis of the fact that 

21 test data is being developed by one or more persons pursuant 

22 to a rule promulgated under subsection (a) , then (unless 

23 such person and the persons referred to in clauses (i) and 

24 (ii) agree on the amount and method of reunbursement) the 

25 Administrator shall issue an order to the person granted the 



73 



17 

1 exemption to provide fair and equitable reimbursement (In 

2 an amount determined under rules of the Administrator) — 

3 (I) to each such person who is> developing such test 

4 data, for a portion of the costs incurred by each such 

5 person in complying with such rule, and 

(J (ii) to any other person who has been required 

7 under this subparagraph to contribute with respect to 

8 the costs of complying with such rule, for a portion of 

9 the amount such person was required to contribute. 

10 In promulgating rules for the determination of fair and 

11 equitable reunbursement to the persons described in clauses 

12 (i) and (ii) for costs incurred with respect to a chemical 

13 substance or mixture^ the Administrator shall, after consul- 

14 tation with the Attorney General and the Federal Trade 

15 Commission, consider all relevant factors, including the 
1(5' effect on competition within the chemical industry and the 

17 share - of thie market for such substance or mixtilre of the 

18 person required to provide reimbursement in relsltion to the 
19^ share of such market of thte persons to be reimbursed. An 

20 .order under ' this subparagraph for purposes of judicial 

21 review shall be considered final agency action. 

22" (Sy i^ exemption' is granted on the basis of the fact 

23 that one or more persons are developing test data pursuant to 

24 a rule promulgated under subsection (a) and if after such 
25' ' exemption is granted the Administrator determines that no 



79-313 O - 77 - 6 



74 



18 

1 such person has complied with such rule, the Administrator 

2 shall (i) after providmg written notice, to the person who 

3 holds such exemption and an opportunity for a hearing, by 

4 order termmate such exemption, and (ii) notify in writing 

5 such person of the requirements of the rule with respect to 

6 which such exemption was granted. 

7 (5) If a person provides reimbursement pursuant to an 

8 order issued under paragraph (3) (A) or (4) (A) in con- 

9 nection with an exemption from a rule promulgated under 

10 subsection (a) , such person may, subject to section 14, have 

11 access to test data the submission or development of which 

12 was the basis for such exemption. 

13 (d) Notice. — Upon the receipt of any test data pur- 

14 suant to a rule under subsection (a) , the Administrator shall 

15 (subject to section 14) publish a notice of the receipt of 

16 such data in the Federal Register and make the data avail- 

17 able to the public within 15 days of receipt. Each such 

18 notice shall (1) identify the chemical substance or mixture 

19 for which data have been received; (2) hst the uses or in- 

20 tended uses of such substance or mixture and the information 

21 required by the applicable standards for the development of 

22 test data; and (3) describe the nature of the test data 

23 developed. 

24 (e) Peioeity List.— (1) (A) There is established 

25 a committee to make recommendations to the Administrator 



75 



19 

1 respecting the chemical substances and mixtures to which the 

2 Administrator should give priority consideration for the 

3 promulgation of a rule under subsection (a) . In makmg such 

4 a determination with respect to any chemical substance or 

5 mixture, the committee shall consider all relevant factors, 

6 including — 



7 (i) the quantities in which the substance or mix- 

8 ture is or will be manufactured, 

9 (ii) the quantities in which the substance or mixture 

10 enters or will enter the environment, 

11 (iii) the number of persons who are or will be 

12 exposed to the substance or mixture in their places of 

13 employment and the duration of such exposure, 

14 (iv) the extent to which humans are or will be ex- 

15 posed to the substance or mixture, 

16 (v) the extent to which the substance or mixture is 

17 -closely related to a chemical substance or mixture which 

18 is known to cause or contribute to an unreasonable risk 

19 to health or the environment, 

20 (vi) the existence of data concerning the effects of 

21 the substance or mixture on health or the environment, 

22 and 

23 (vii) the extent to which testing of the substance 

24 or mixture may result in the development of data upon 

25 which the effects of the substance or mixture on health 



76 



20 

1 or the environment can reasonably be detenmned or 

2 predicted. 

3 The reconmiendations of the committee shall be in the form 

4 of a list of chemical substances and mixtures which shall 

5 be hs'ted, either by individual substance or mixtui'e or by 

6 groups of substances or mixtures, in the order in which the 

7 committee deteraiines the Admmistrator should take action 

8 under subsection (a) with respect to the substances and 

9 mixtures. The committee shall give priority attention in 
30 estabhshing such list to those chemical substances and mix- 

11 tures which are known or are suspected of causing or con- 

12 tributing to (i) cancer, (ii) gene mutations, or (iii) birth 

13 defects. 

14 (B) As soon as practicable but not later than nme 

15 months after the date of the enactment of this Act, the com- 

16 mittee shall pubUsh in the Federal Register the Ust required 

17 by subparagraph (A) together with the reasons for the com- 

18 mittee 's inclusion of each chemical substance or mixture on 

19 the Hst. At least every 6 months after the pubhcation of 

20 the list pursuant to the preceding sentence, the committee 

21 shall make such revisions in the list as it determines to be 

22 necessary and shall pubhsh the list in the Federal Kegister 

23 with the committee's revisions (if any) and the reasons for 

24 the revisions. Within the 12-month period be^nning on the 

25 date of the inclusion of a chemical substance or mixture on 



77 



21 

1 such a list the Administrator shall with respect to such 

2 chemical substance or mixture either (i) initiate a rule- 

3 making proceeding under section 4 (a) or (ii) if such a 

4 proceeding is not initiated within such period, publish in 

5 the Federal Register the Administrator's reasons for not 
Q initiating such a proceeding. 

7 (C) The Administrator may promulgate a rule under 

8 subsection (a) with respect to a chemical substance or mix- 

9 ture (i) wliidi is not contained on a list published under 

10 this subsection or (ii) whether or not the Administrator has 

11 published in the Federal Register reasons for not initiating 

12 a proceeding under subparagraph (B) . 

12, (2) (A) The committee established by paragraph (1) 

14 (A) shall consist of seven members as follows : 

15 (i) One member (or designee of the member) 

16 appointed from the Department of Commerce by the 

17 ■ Secretary. 

18 (ii) One member (or designee of the member) 

19 appointed from the Environmental Protection Agency 

20 by the Administrator. 

21 (iii) One member (or designee of the member) 

22 appomted by the Secretary of Labor from officers of 

23 the Department of Labor engaged in the Secretary's 

24 activities under the Occupational Safety and Health 

25 Act of 1970. 



78 



22 

1 (iv) One member (or designee of the member) 

2 'appointed from the Council on Environmental Quality 

3 by the Chairman of the Council. 

4 (v) One member (or designee of the member) 

5 appointed from the National Institute for Occupational 

6 Safety and Health by the Director of the Institute. 

7 (vi) One member (or the designee of the member) 

8 appointed from the National Institute of Environmental 

9 Health Sciences by the Director of the Institute. 

10 (vii) One member (or designee of the member) 

11 appointed from the National Cancer Institute by the 

12 Director of the Institute. ^ 

13 (^iii) One member (or designee of the member) 

14 appointed from the National Science Foundation by 
35 the Dh'ector of the Foundation. 



K) A member may designate an individual to serve on the 

17 member's behalf only with the approval of the applicable 

18 appomtmg authority and only if the individual is from the 

19 entity from which the member was appointed. A vacancy in 

20 the committee shall be filled in the same manner m which 

21 the original appointment was made. 

22 (^) (i) The term of office of a member of the committee 

23 is 4 years, except that of the members first appointed, 

24 four members shall have initial terms of 2 years. Any 



79 
23 

1 member appointed to fill a vacancy occurring prior to the 

2 expiration of the term for which the member's predecessor 

3 was appointed shall be appointed only for the remainder of 

4 such term. If any member of the committee leaves the office 

5 or entity from which the member was appointed, such mem- 
G ber's term of office shall be terminated and the member's 

7 position shall be considered as being vacant. A member may 

8 serve after the expiration of the member's term of office until 

9 a successor has taken office. Members may be reappointed. 

10 (ii) Initial appointments to the committee shall be 

11 made not later than the 60th day after the date of the 

12 enactment of this Act. Not later than the 90th day after 

13 such date of enactment the members of the committee shall 

14 hold a meeting for the selection of a chairman from among 

15 their number and to determine, by lot, the four members 

16 who shall have initial tenns of 2 years. 

17 (C) (i) No member of the committee, or designee of 

18 such member, shall accept employment or compensation 

19 from any person subject to any requirement of this Act, or 

20 rules issued thereunder, for a period of at least 24 months 

21 after termination of employment with such agency. 

22 (ii) No person, while serving as a member of such 

23 committee, or designee of such member, may own any stocks 

24 or bonds, or have any pecuniary interest in any firm, asso- 



80 



24 

1 elation, or corporation engaged m the manufactiu'e, process- 

2 ing, or distribution of any chemical substance or mixture 

3 subject to the provisions of this Act. 

4 (iii) The Administrator or the Attorney General may 

5 bring an action in the appropriate district court of the United 

6 States to restrain any violations of this subparagraph. 

7 (D) The Administrator shall provide tiie committee 

8 such administrative and stafif support services as may be 

9 necessary for the committee to carry out its functions under 

10 this subsection. 

11 (f) Eequieed Actions. — (1) Upon tiie receipt of 

12 (A) any test data required to be submitted under this secth)n 

13 or under sectipn 5, or (B) any other information available to 

14 the Administrator which indicates that a chemical substance 

15 or mixture has the potential, at levels for which human ex- 

16 posure exists or may exist and with appropriate safety mar- 

17 gins, to induce in human beings (1) cancer, (2) gene 

18 mutations, or (3) birth defects, the Administrator shall take 

19 appropriate action under section 5 (e) , 6 (a) , or 7, within 

20 180 days after the receipt of such data or information to Umit 

21 exposure of human beings with respect to such substance or 

22 mixture, or he shall publish m the Federal Register his find- 

23 ing that no unreasonable risk of injury is presented and rea- 

24 sons tiicrefor. Any such finding under this subsection that no 



81 
25 

1 unreasonable risk is presented shall be reviewable in accord- 

2 ance with chapter 7 of title 5, United States Code^ 

3 (2) Nothing contained in this subsection shall require 

4 the Administrator to take action under section 5 (e) , 6 (a) , 

5 or 7, or publish his reasons for failing to take such action, 

6 until 2 years after the date of enactment of this Act. 

7 PEEMARKET NOTIFICATION OF CHEMICAL SUBSTANCES 

8 Sec. 5. (a) General.— (1) Commencing 1 year and 

9 30 days after the date of enactment of this Act, a 

10 manufacturer shall notify the Administrator, who shall 

11 notify the public as required in subsection (c) , of any 

12 planned manufacture of a new ^^hemical substance, at least 

13 90 days prior to the commencement of such manufacture. 

14 Such notice to the Administrator shall be accompanied by 

15 all pertinent information referred to in section 8(a) (2), 
1^ whether or not the Administrator has required the siibmis- 
1'^ sion thereof under section 8(a) (2) . except that with respect 

18 to the information referred to under section 8(a) (2) (E), 

19 such manufacturer may submit a description of such infor- 

20 mation, as defined by the Administrator, by rule. 

21 (2) The Administrator shall give priority attention to 

22 a chemical substance with respect to which information is 

23 received indicating that serious economic or other hardships 

24 are likely to result if there is any delay in manufacture. 



82 



26 

1 If the Administrator finds that such a substance does not 

2 present an unreasonable risk to human health and the 

3 environment, he may reduce the number of days, after sub- 

4 mission of such infoimation, during which manufacture may 

5 not occur. The Administrator shall promptly pubhsh (sub- 

6 ject to section 14) his findings and the basis therefor in the 

7 Federal Eegister. 

8 (b) Submission of Data. — Any manufacturer of a 

9 new chemical substance that is covered by section 4 (a) shall 

10 submit to the Administrator (in addition to the information 

11 required in subsection (a) ) the data developed in accord- 

12 ance with such requirement .at least 90 days prior to such 

13 manufacture, and the Administrator shall make it pubhcly 

14 available in accordance with subsection (c) . 

15 (c) Data Availability. — Within 15 days after re- 

16 ceipt, the Administrator shall promptly publish in the Fed- 

17 eral Eegister (subject to section 14) the identity of each 

18 chemical substance for which a notice has been received un- 

19 der subsection (a) or (b) , the intended use or distribution 

20 of such substance, and a statement that the data and other 

21 information is available. The 90 days referred to in subsec- 

22 tions (a) and (b) shall begin upon pubHcation under this 

23 subsection in the Federal Register. 

24 (d) Extension. — The Administrator may extend, for 

25 an additional period beyond the 90-day period referred to 



83 



27 

1 in subsection (a) or (b) , the date after which a new chemi- 

2 cal substance may be manufactured. Such additional period 

3 may not exceed 90 days and shall not be imposed except 

4 for good cause shown. Notice of any such extension, and 

5 the reasons therefor, shall be pubhshed (subject to section 

6 14) in the Federal Register. Such an extension shall consti- 

7 tute a final action for purposes of judicial review. 

8 (e) Ordees.— ( 1 ) (A) If the Administrator finds, dur- 

9 ing the 90-day period referred to in subsection (a) or (b) 

10 or during any extension thereof, with respect to any new 

11 chemical substance for which notification is required under 

12 this section — 

13 (i) that such new chemical substance is covered by 

14 a test requirement under section 4(a), but that such 

15 requirement requires additions or revisions with respect 
IG to such substance ; or 

17 (ii) that such new chemical substance is not cov- 

18 ered by such a requirement under section 4(a), but 

19 that such requirement should be estabhshed; 

20 he shall issue an order in accordance with this subsection. 

21 Such an order shall appropriately prohibit or restrict the 

22 manufacture, processing, distribution in commerce, use, or 

23 disposal of such new chemical substance pending the comple- 

24 tion of a rulemaking proceeding under section 4(a) and 

25 the submission of any data required thereunder, as described 



84 

28 

^ tinder sul)paragraph (B) ; shall contain a proposed rule 

2 under section 4(a) ; and shall be immediately effective. 

2 (B) Upon the issuance of any order under subpara- 

^ gi'aph (A) , the Administrator shall proceed with a rulemak- 

g ing procedure as expeditious^ as practicable under section 4 

Q (a) and in accordance with subparagraph (C) . During the 

rj course of, or upon the completion of, such rulemaking, the 

g Administrator shall, if necessary, appropriately modify or 

g rescind any order issued under subparagraph (A). If any 

-^Q testing requirements are established as a result of such rule- 

j^-j^ making, any proAdsion of such order restricting the manu- 

■J2 facture, processing, distribution in commerce, use, or disposal 

-J3 of such substance shall remain in eflfect, unless modified or 

■j^^ rescinded, pending the submission of such data to the Ad- 

-|5 ministrator and the completion of procedures described in 

■^Q subsection (b) or any extension imposed under subsection 

17 (d). 

(C) If Administrator issues an order under sub- 

-j^g paragraph (A), the Administrator shall provide interested 

2Q persons reasonable opportunity, in accordance with section 

21 4(b) (4) to make presentations and submissions with re- 

22 spect to such order. If such presentation or submission is 

23 requested, the Administrator shall comply within 30 days 

24 from the date such request is made unless the Administra- 

25 tor and the person making the request agree upon a later 



85 



29 

1 date. Within 10 days after such presentations and submis- 

2 sion are concluded, the Administrator shall consider such 

3 presentations and submissions and affirm, modify, or revoke 

4 such order. 

5 (2) (A) If the Admmistrator finds, during the 90-day 

6 period referred to in subsection (a) or (b) or during any 

7 extension thereof, with respect to any new chemical substance 

8 for which notification is required under this section, that a 

9 rule is appropriate under section 6(a), he shall issue an 

10 order in accordance with this subsection, Such an order. 

11 shall appropriately prescribe such requirements as are au- 

12 thorized under section 6(a) ; shall contain a proposed rule 

13 under section 6 (a) ; and shall be immediately effective. 

1-1 (B) Upon the issuance of any order under subpara- 

15 graph (A), the Administrator shall proceed with a rule- 

16 making procedure as expeditiously as practicable imder sec- 

17 tion 6(a) and in accordance wdth subparagraph (C) . 

18 During the course of, or upon the completion of such rule- 

19 making, the Administrator shall> if necessary, appropriately 

20 modify or rescmd any order issued under subparagraph ( A) . 

21 (C) If the Administrator issues an order under sub- 

22 paragraph (A), the Administrator shall provide interested 

23 persons reasonable opportunity^, in accordance with section 

24 6(c) (2) and (3) for an mformal hearing wdth respect to 

25 s,uch order. If such hearing is requested, the Administrator 



86 



30 

1 shall comply within 30 days from the date such request is 

2 made unless the Administrator and the person making the 

3 request agree upon a later date. Within 10 days after such 

4 hearing is concluded, the Administrator shall consider the 

5 information presented at such hearing and affirm, modify, 

6 or revoke such order. 

7 (f) Statement of Reasons foe I^ot Taking Ac- 

8 TioN. — Prior to the expiration of 90 days after the date 

9 of publication under subsection (c) , of data and informa- 

10 tion with respect to a new chemical substance, or prior to 

11 the expiration of such period as extended under subsection 

12 (d), the Administrator shall publish a statement of his 

13 reasons in the Federal Register, if he decides not to take 

14 action under subsection (e) or section 7 with respect to 

15 s,uch chemical substance during such period. Manufacture 

16 may commence following publication of the Administrator's 

17 statement. The Admniistrator's failure to issue such an order 

18 under subsection (e) or take action under section 7 is an 

19 action subject to judicial review in accordance with section 

20 19. Nothing in this subsection prohibits the Administrator 

21 from — 

22 ( 1 ) promulgating a rule pursuant to section 6 or 4, 

23 with respect to such a substance, after such manufacture 

24 has commenced; 

25 (2) taking action against any chemical substance 



87 



31 

X which is found to be an imminent hazard pursuant to 

2 section 7 ; or 

3 (3) taking any other action authorized by this Act. 

4 (g) Exemption. — (1) The Administrator may upon 

5 application (made in such form and manner as the Adminis- 

6 trator may prescribe) exempt any person from the require- 

7 ment of subsection (b) or (h) to submit data for a chemical 

8 substance or mixture. If, upon receipt of an appHcation 

9 under the precedmg sentence, the Administrator determines 

10 that^ 

11 (A) the chemical substance or mixture with respect 

12 to which such application was submitted is equivalent 

13 to a chemical substance or mixture for which data has 

14 been submitted to the Administrator in accordance with 

15 subsection (b) or (h),and 

16 (B) submission of data by the applicant with re- 

17 (spect to such substance would be duplicative of data 

18 which has been submitted to the Administrator in 

19 accordance with such subsection, 

20 the Administrator shall exempt the applicant from submit- 

21 ting such data with respect to such substance. No exemption 

22 granted under this subparagraph with respect to the submis- 

23 sion of data for a chemical substance or mixt^e may take 

24 effect before the beginning of the reimbursement period 

25 applicable to such data. 



88 



32 

1 (2) If the Administrator, under paragraph (1), ex- 

2 empts any person from submitting under subsection (b) or 

3 (h) data for a chemical substance or mixi.ture because of 

4 the existence of previously submitted data and if such exemp- 

5 tion is granted during the reimbursement period for such 

6 data, then (unless such person and the persons referred to 

7 in subparagraphs (A) and (B) agree on the amount and 

8 method of reimbursement) the Administrator shall order the 

9 person granted the exemption to provide fair and equitable 

10 reimbursement (in an amount determined under rules of the 

11 Administrator) — 

12, (A) to the person who previously submitted the 

13, data on which the exemption was basedj for a portion of 

14 the costs incurred by such person in complying' with the 

15 requirement under subsection (b) or (h) to submit 

16 such data, and 

17 (B) to any other person who has been required 

18 under this subparagraph to contrib,ute with respect to 

19 such costs, for a portion of the amount -such' person 

20 was required to contribute. 

21 In promulgating rules for the determination of fair and 

22 equitable reimbursement to the. persons described -in sub- 

23 paragraphs (A) and (B) for costs incurred with respect to 

24 a chemical substance or mixture, the Administrator shall, 

25 after consulting with the Attorney General and the Federal 



89 



33 

1 Trade Commission, consider all relevant factors, including 

2 the effect on competition within the chemical industry and 

3 the share of the market for such s.ubstance or mixture of the 

4 person required to provide reimbursement in relation to the 

5 share of such market of the persons to he reimbursed. An 

6 order under tliis subparagraph shall be considered final 

7 agency action, for purposes of judicial review. 



8 (3) For purposes of this paragraph, the reimbursement 

9 period for any previously submitted data for a chemical 

10 substance or mixture is a period — 

11 (A) beginning on the date of the termination of 

12 the prohibition, imposed under this section, on the manu- 

13 facture or processing of such s.ubstance by the person 

14 who submitted such data to the Administrator, and 

15 (B) ending— 

16 (i) two years after the date referred to in 

17 subparagraph (A), or 

18 (ii) at the expiration of a period which begins 

19 on the date referred to in subparagraph (A) and is 

20 equal to the period which the Administrator deter- 

21 mines was necessary to develop such data, 

22 whichever is later. 

23 (h) Significant New Use.— (1) Within 6 months 

24 after the date of enactment of this Act, and from time to 

25 tune thereafter, the Administrator shall, by rule, establish 

S.3149 3 



79-313 O - 



77 - 7 



90 



34 

1 criteria defming a significant new distribution in commerce, 

2 use, or disposal of a chemical substance. In establishing such 

3 criteria, the Administrator shall take into account — 



4 (A) projected volume of production; 

5 (B) projected category or categories of uses; 

6 (C) projected increase in magnitude and duratiori 

7 of human and environmental exposure; 

8 (D) route or routes of exposure of human beings 

9 or of the environment that are attributable to such 

10 signficant new use; and 

11 (E) the human health and environmental effects 
12, thereof. 

13 (2) A chemical substance may not be manufactured or 



14 processed for a distribution in conamerce, use, or disposal 

15 that is identified by the Administrator, in a rule, as a sig- 

16 nificant new distribution in conamerce, use, or disposal, unless, 
1^7 at least 90 days prior to such manufacture or processing, 

18 the person intending to manufacture or process such substance 

19 for such distribution in commerce, use, or disposal submits a 

20 notice of his intention to do so and any data required to be 

21 developed under section 4 (a) to the Administrator. Any such 

22 use of such substance shall be subject to all of the provisions 

23 of this section. 

24 (i) Special Exemption.— The Administrator may, 



91 



35 

^ upon application and by rule, exempt any person from the 

2 foregoing requirements of this section — 

3 (1) for the purpose of permitting such person to 

4 manufacture, process, distribute in commerce, use, or 

5 dispose of a new chemical substance to which a rule 
Q under section (a) is applicable for test marketing pur- 

7 poses or specially limited purposes (A) upon a show- 

8 ing by such person that such activity will not cause or 

9 contribute to an unreasonable risk of injury to human 

10 health or the environment, and (B) under such restric- 

11 tions as the Administrator considers appropriate; or 

12 (2) to the extent that such person manufactures 

13 chemical substances which are intermediate reaction 

14 products formed during the manufacture of other chem- 

15 ical substances and for which there is no exposure to 

16 human beings or the environment. 

17 (j) MiXTUEES— The Administrator is authorized to 

18 specify any mixture which shall be subject to the provisions 

19 of this section. 

20 (k) Experimentation. — The requirements of subsec- 

21 tions (a), (b), and (h) do not apply to any chemical sub- 

22 stance which is manufactured or intended to be manufactured 

23 only in small quantities (as defined by the Administrator 

24 by rule) solely for scientific experimentation or analysis or 



92 



36 

' i for chemical .research or analysis, including such research 

2 or analysis for the development of a product, except that 

3 the Administrator may, by rule, include such chemical sub- 

4 stances upon a finding that the manufacture, processing, dis- 
•5 tribution in coimnerce, use, or disposal of such chemical sub- 

6 stances may cause or contribute to an unreasonable risk of 

7 injury to human health or the environment. 

8 EEGULATION OF CHEMICAL SUBSTANCES 
" AND MIXTURES 

-10 Sec. 6. (a) Scope of Regulation — ( 1 ) If the Ad- 

11 minis tra tor finds that the manufacture, processing, distribu- 

12 tion in commerce, use, or disposal of a chemical substance 

13 or mixture presents or is likely to present an unreasonable 
-14 'risk of iitjury to health or the environment, the Adminis- 

15 tiator shall by rule apply to such substance or mixture one 

16 or more of the following requirements as is necessary to 

17 adequately protect against such risk: 



18 * (A) A requirement prohibiting the manufacturing, 

19 processing, or distribution in commerce of such substance 
-20 ' or mixture or limiting the amount of such substance or 
'21 ' mixture which may be manufactured, processed, or dis- 
'22 tributed in conunerce. 

23 (B) A requirement— 

*24: (I) prohibiting the manufacture, processing 

25 or distribution in commerce of such substance or 



93 



37 

1 mixture for (i) a particular use or particular u^s 

2 or (ii) a particular use or particular uses ini:a 

3 concentration in excess of a level specified by the 

4 Administrator in the rule imposing the requirement, 

5 or 

6 (II) limiting the amount of such substance or 

7 mixture which may be manufactured, processed, 

8 or distributed in commerce for (i) a particular use 

9 or particular uses or (ii) a particular use or par- 

10 ticular uses in a concentration in excess of a level 

11 specified by the Administrator in the rule imposing 

12 the requirement. : r 

13 (C) A requirement regulating the manner or meth<)d 

14 of Use or disposal of such substance or mixture. 

15 (I^) A requirement that such substance or mixture 

16 or any article containing such substance or ipixture be 
1'^ marked with or accompanied by clear and adequate 

18 warnings and instructions with respect to its distribution 

19 in commerce, use, or disposal. The form and content of 

20 such warnings and instructions shall be prescribed by 

21 the Administrator. 

22 (E) A requirement directing manufacturers or 

23 processors of such substance or mixture (i) to give 

24 notice of such unreasonable risk of injury to distrib- 



94 



38 

1 utors in commerce of such substance or mixture and, 

2 to the extent reasonably ascertainable, to other pei*sons 

3 in possession of such substance or mixture or exposed 

4 to such substance or mixture, (ii) to give public notice 

5 of such risk of injury, and (iii) to either replace or re- 

6 purchase such substance or mixture whichever the person 

7 to which the requirement is dhected elects. 

8 t^") -A. requirement that manufacturers and proc- 

9 essors of such substance or mixture make and retain 

10 records of the processes used to manufacture or process 

11 such substance or mixture and monitor or conduct tests 

12 which are reasonable and necessary to assure compliance 

13 with the requirements of this subsection. 

14 A requirement imposed under this subsection may be limited 

15 in application to specified geographic areas. 

16 (2) Rules limiting the amount of a chemical substance 

17 or mixture which may be manufactured, processed, or distrib- 

18 uted in commerce, or hmiting the amount of such substance 

19 which may be manufactured, processed, or distributed for a 

20 particular use, shall, upon the petition of any manufacturer, 

21 processor, or distributor in commerce thereof, provide for as- 

22 signing production, processing, and distribution quotas, to the 

23 extent necessary, with respect to the chemical substance in- 

24 volved. The permissible quota for each person who applies to 

25 manufacture, process, or import such substance or to engage 



95 



a9 

1 in its distribution in commerce shall be determined in accord- 

2 ance with fair and equitable criteria which the Secretary of 

3 Commerce, in consultation with the Administrator and the 

4 Attorney General, shall prescribe by rule. Such criteria shall 

5 take into account all relevant factors, including (A) effects on 

6 competition; (B) the market shares, productive capacity, 

7 and product and raw material inventories of the precursors 

8 of the chemical substance or mixture of persons applying for 

9 quotas; (C) emergency conditions; and (D) effects on 

10 technological innovation. 

11 (3) (A) Prior to the issuance of a quota under para- 

12 graph (2), the persons who apply under such paragraph 

13 shall attempt to develop a voluntary agreement limiting the 

14 quantities which each such person shall manufacture, process, 

15 import, or distribute. The availability of immunity from the 

16 antitrust laws with respect to the development of such volun- 

17 tary agreement shall be Hmited to the provisions of this 

18 subsection. 

19 (B) The Secretary of Commerce, with the approval of 

20 the Attorney General, after each of them has consulted with 

21 the Federal Trade Commission, shall prescribe, by rule, 

22 standards and procedures by which persons seeking to manu- 

23 facture, process, import, or otherwise distribute a chemical 

24 substance or mixture for which limitations on quantity have 

25 been prescribed pursuant to paragraph (B) (II) of subsec- 



96 



40 

1 tion (a) of this section may develop and carry out such 

2 voluntary agreements as are permissible pursuant to this 

3 subsection. 

4 (C) The standards and procedures prescribed under 

5 subparagraph (A) shall include the following requirements: 

6 (i) Meetings held to develop or carry out a volun- 

7 tary agreement under this subsection shall permit at- 
•8 ■ tendance by representatives of Committees of Congress 

9 and interested persons, including all persons interested 

10 in the chemical substance or mixture involved, and the 

11 public; shall be preceded by timely and adequate notice 

12 with identification of the agenda of such meeting to the 

13 Secretary of Commerce, the Attorney General, the Fed- 
11 era! Trade Commission, the Administrator and the pub- 

15 lie; and shall be chaired by a regular full-time Federal 

16 employee. 

,17 (ii) ^ full and complete record, and where prac- 

18 ticable a verbatim transcript, shall be kept of any 

19 meeting held, and a full and complete record shall be 

20 kept of any communication (other than in a meeting) 

21 made, between or among participants or potential par- 

22 ticipants, to develop, or carry out a voluntary agree- 

23 ment under this subsection. Such record or transcript 

24 shall be deposited, together with any agreement result- 

25 ing therefrom, with the Secretary of Commerce and 

26 the Administrator and shall be available to the Attor- 



97 



41 

1 ney General and the Federal Trade Commission. Such 

2 records or transcripts shall be available for public 

3 inspection and copying in accordance with section 552 

4 of title 5, United States Code. 

5 (I^) (i) The Attorney General and the Federal Trade 

6 Commission shall participate from the beginning in the 

7 development, and when practicable, in the carrying out of 

8 voluntaiy agreements and plans of action authorized under 

9 this section. Each may propose any alternative which would 

10 void or overcome, to the greatest extent practicable, possible 

11 anticompetitive effects while achieving substantially the pur- 

12 poses of this subsection. A voluntary agreement under this 

13 subsection may not be carried out unless approved by the 

14 Attorney General, after consultation with the Federal Trade 

15 Commission. Prior to the expiration of the 20-day period 

16 prescribed under clause (ii) , the Federal Trade Commission 

17 shall transmit to the Attorney General its views as to 

18 whether such an agreement or plan of action should be 

19 approved, and shall publish such views in the Federal Reg- 

20 ister. The Attorney General, in consultation with the Federal 

21 Trade Conunission, and the Secretary, shall have the right 

22 to review, amend, modify, disapprove, or revoke, on his 

23 o^Ti motion or upon the request of the Federal Trade Com- 

24 mission or any interested person, any voluntary agreement 

25 at any time, and, if revoked, thereby withdraw prospectively 



98 



42 

1 any immunity which may be conferred by subparagraphs 

2 (F)or(I). 

3 (ii) Any voluntary agreement entered into pursuant to 

4 this section shall be submitted in writing to the Attorney 

5 General and the Federal Trade Commission 20 days before 

6 being implemented. Any such agreement shall be available 

7 for public inspection and copying, to the extent to which 

8 records or transcripts are so available as provided in the 

9 last sentence of subparagraph (C) (ii) . Any action taken 

10 pursuant to such voluntary agreement or plan of action 

11 shall be reported to the Attorney General and the Federal 

12 Trade Commission pursuant to such regulations as shall be 

13 prescribed under clauses (iii) and (iv) of subparagraph 

14 (E). 

15 (E) (i) The Attorney General and the Federal Trade 

16 Commission shall monitor the development and carrying 

17 out of voluntary agreements authorized under this para- 

18 graph in order to promote competition and to prevent 

19 anticompetitive practices and effects. 

20 (ii) In addition to any requirement specified under 

21 subparagraph (B) and (C) of this paragraph and in order 

22 to carry out the purposes of this section, the Attorney Gen- 

23 eral, in consultation with the Federal Trade Conmiission 

24 and the Administrator, shall promulgate rules concerning 

25 the maintenance of necessary and appropriate records re- 



99 



43 

1 lated to the development and carrying out of voluntaiy 

2 agreements authorized pursuant to this section. 

3 (iii) Persons developing or canying out voluntary 

4 agreements authorized pursuant to this section shall main- 

5 tain such records as are required by rules promulgated 

6 under subparagraph (B) . The Attorney General and the 

7 Federal Trade Commission shall have access to and the 

8 right to copy such records at reasonable times and upon 

9 reasonable notice. 

10 (iv) The Attorney General and the Federal Trade Com- 

11 mission may each prescribe such rules as may be necessar}^ or 

12 appropriate to carry^ out their respective responsibihties under 

13 this section. They may both utilize for such purposes and for 

14 purposes of enforcement any powers conferred upon the 

15 Federal Trade Conamission or the Department of Justice, or 

16 both, by the antitrust laws or the Antitrust Civil Process Act; 

17 and wherever any such law refers to ''the pui"poses of this 

18 Act'' or like terms, the reference shall be understood to in- 

19 elude this subsection. 

20 (F) (i) There shall be available as a defense to any 

21 civil or criminal action brought under the antitrust laws 

22 (or any similar State law) in respect to actions taken to 

23 develop or carry out a voluntary agreement by persons 

24 engaged in the business of manufacturing, processing or dis- 

25 tributing such chemical substance or mixture (provided that 



100 



44 

1 such actions were not taken for the purpose of injuring 

2 competition) that — 

3 (I) such actions were taken in the course of de- 

4 veloping a voluntary agreement pursuant to this para- 

5 graph to carry out a voluntary agreement authorized 

6 and approved in accordance with this section, and 

7 (II) such persons complied with the requirements 

8 of this paragraph and the rules promulgated here- 

9 under. 

10 (ii) Persons interposing the defense provided by this 

11 paragraph shall have the burden of proof, except that the 

12 burden shall be on the person against whom the defense 

13 is asserted with respect to whether the actions were taken 

14 for the purpose of injuring competition. 

15 (G) No provision of this section shall be construed 

16 as granting immunity for, or as hmiting or in any way 

17 affecting any remedy or penalty which may result from any 

18 legal action or proceeding arising from, any act or practice 

19 which occurred prior to the date of enactment of this Act 

20 or subsequent to its expiration or repeal. 

21 (H) The Attorney General and the Federal Trade 

22 Commission shall each submit to the Congress and to the 

23 President, at least once each year a report on the impact 

24 on competition and on small business of actions authorized 

25 by this section. 



101 



45 

1 (I) In any action in any Federal or State court for 

2 breach of contract, there shall be available as a defense 

3 that the alleged breach of contract was caused predomi- 

4 nantly by action taken to carry out a voluntary agree- 

5 ment authorized and approved in accordance with this 

6 paragraph. 



7 (J) As used in this paragraph, the term ''antitrust 

8 laws" hicludes — 

9 (i) the Act entitled "An Act to protect trade and 

10 commerce against unlawful restraints and monopolies", 

11 approved July 2, 1890; 

12 (ii) the Act entitled *'An Act to supplement exist- 

13 ing laws against unlawful restraints and monopolies, 

14 and for other purposes", approved October 15, 1914; 

15 (iii) the Federal Trade Commission Act; 

10 (iv) sections 73 and 74 of the Act entitled ''An Act 

17 to reduce taxation, to provide revenue for the Govem- 

18 ment, and for other purposes", approved August 27, 

19 1894; and 

20 (v) tbe Act of June 19, 1936, chapter 592. 

21 (b) Quality Control. — (1) If the Admuaistrator 

22 has good cause to beheve that a particular manufacturer or 

23 processor is manufacturing or processmg a chemical sub- 

24 stance or mixture in a manner which causes the adultera- 

25 tion of a chemical substance or mixture — 



102 
46 

1 (A) the Administi-ator may by order require such 

2 manufactui'er or processor to submit a description of the 

3 relevant quality control procedures followed in the man- 

4 ufacturing or processing of such chemical substance or 

5 mixture ; and 

6 (B) if the Administrator thereafter determines on 

7 the record, after opportunity for hearing in accordance 

8 with section 554 of title 5, United States Code, that 

9 such quality control procedures are inadequate to pre- 

10 vent the chemical substance or mixtm*e from causing or 

11 contributing to such risk, the Administrator may order 

12 the manufacturer or processor to revise such quality 

13 control procedures to the extent necessary to remedy 

14 such inadequacy. 

15 (2) As used in this section, a chemical substance or 

16 mixture is adulterated if the manner in which it is manu- 

17 factured or processed causes it to contain a particular mo- 

18 lecular identity, an uncombined radical, an element, or any 

19 combination thereof, which is found by the Administrator 

20 to cause or contribute to an unreasonable risk of injury to 

21 human health or the environment. 

22 (c) Promulgation of Subsection (a) Rules.— 

23 (1) In promulgating any rule under subsection (a) with 

24 respect to a chemical substance or mixture, the Adminis- 



103 



47 

1 trator shall consider relevant factors and make findings 

2 with respect thereto, including — 

3 (A) the risks presented by such substance or mix- 

4 ture to health and the magnitude of human exposure to 

5 such substance or mixture. 

6 (B) the risks presented by such substance or mix- 

7 ture to the environment and the magnitude of environ- 

8 mental exposure to such substance or mixture, 

9 (C) the benefits of such substance or mixture for 

10 such use or uses and the availability of other substances 

11 or mixtures for such use or uses, and 

12 (D) the reasonably ascertainable economic conse- 

13 quences of the rule, including consideration of the 

14 effect on the national economy, innovation, the environ- 

15 ment, and pubhc health. 

16 Findings made under this paragi'aph shall be published in 

17 the Federal Register. 

18 (2) When prescribing a rule under subsection (a) the 

19 Administi'ator shall proceed in accordance with section 553 

20 of title 5, United States Code (without regard to any 

21 reference in such section to sections 556 and 557 of such 

22 title) , and shall also (A) publish a notice of proposed rule- 

23 making statmg with particularity the reason for the pro- 

24 posed rule; (B) allow interested persons to submit written 

25 data, views, and arguments, and make all such submissions 



104 



48 

1 publicly available; (C) provide an opportunity for an in- 

2 formal bearing in accordance witb paragraph (3) ; and (D) 

3 promulgate, if appropriate, a final rule based on the matter 

4 in the rulemaking record. 

5 (3) The Administrator shall conduct informal hearings 

6 required by paragraph (2) (C) of this subsection in ac- 

7 cordance with the following procedure: 

8 (A) Subject to subparagraph (B) of this para- 

9 graph, an interested person is entitled — 

10 (i) to present his position orally or by docu- 

11 mentary submissions (or both) , and 

12 (ii) if the Admmistrator determines that there 

13 are disputed issues of material fact it is necessary 

14 to resolve, to present such rebuttal submissions and 

15 to conduct (or have conducted under subparagraph 

16 (B) (ii) ) such cross-examination of persons as 

17 the Administrator determines (I) to be appropriate, 

18 and (II) to be required for a full and true dis- 

19 closure with respect to such issues. 

20 (B) The Administrator may prescribe such rules 

21 and make such rulings concerning proceedings in such 

22 hearings to avoid unnecessary costs or delay. Such rules 

23 or rulings may include (i) imposition of reasonable time 

24 limits on each interested person's oral presentations, and 

25 (ii) requirements that any cross-examination to which 



105 



49 

1 a person may be entitled under subparagraph (A) be 

2 conducted by the Administrator on behalf of that person 

3 in such manner as the Administrator determines (I) to 

4 be appropriate, and (II) to be required for a full and 

5 true disclosure with respect to disputed issues of material 

6 fact. 

7 (C) (i) Except as provided in clause (ii) , if a group 

8 of persons each of whom under subparagraphs (A) and 

9 (B) would be entitled to conduct (or have conducted) 

10 cross-examination and who are determined by the Ad- 

11 ministrator to have the same or similar interests in the 

12 proceeding cannot agree upon a single representative of 

13 such interests for purposes of cross-examination, the Ad- 

14 ministrator may make rules and rulings (I) limiting the 

15 representation of such interest for such purposes, and 

16 (II) governing the manner in which such cross-exami- 

17 nation shall be limited. 

18 • (ii) When any person who is a member of a group 

19 with respect to which the Administrator has made a 

20 detennination under clause (i) is unable to agree upon 

21 group representation with the other members of the 

22 group, then such person shall not be denied under the 

23 authority of clause (i) the opportunity to conduct (or 

24 have conducted) cross-examination as to issues affecting 

25 his particular interests if (I) he satisfies tlie Administra- 
S.3149 4 



79-313 O - 77 - 8 



106 



50 

1 tor that he has made a reasonable and good faith effort 

2 to reach agreement upon group representation with the 

3 other members of the group and (II) the Administrator 

4 determines that there are substantial and relevant issues 

5 which are not adequately presented by the group rep- 

6 resentative. 

7 (D) A verbatim transcript shall be taken of any 

8 oral presentation, and cross-examination, in informal 

9 hearings under this subsection. Such transcript shall be 

10 available to the public. 

11 (E) A substantive amendment to, or repeal of, a 

12 rule promulgated under subsection (a) shall be pre- 

13 scribed, and subject to judicial review, in the same man- 

14 ner as a rule prescribed under such subsection. 

15 (4) Any rule promulgated under this section shall be 

16 judicially reviewable in accordance with section 19, except 

17 that in addition to any basis for holding unlawful or setting 

18 aside the rule under subparagraphs (A), (B), (C), or (D) 

19 of section 706(2) of title 5, United States Code, the court 

20 shall hold unlawful and shall set aside the rule if the court 

21 finds that— 

22 (A) the Administrator's determination under para- 

23 graph (3) that the petitioner is not entitled to conduct 

24 cross-examination or make rebuttal submissions, or 

25 (B) the Administrator's rule or ruling under para- 



107 



51 

1 graph (3) limiting the petitioner's cross-examination or 

2 rebuttal submissions, 

3 has precluded disclosure of disputed material facts which 

4 was necessary for fair determination by the Administrator 

5 of the rulemaking proceeding taken as a whole. 

6 (5) (A) The Admmistrator may, pursuant to rules 

7 proscribed by him, provide compensation for reasonable attor- 

8 neys fees, expert witness fees, and other costs of participating 

9 in a rulemaking proceeding under this section to any person 

10 (i) who has, or represents an interest (I) which would not 

11 otherwise be adequately represented in such proceeding, and 

12 (II) representation of which is necessary for a fair determi- 

13 nation of the rulemaking proceeding taken as a whole, or 

14 (ii) who is unable effectively to participate in such proceed- 

15 ing because such person cannot afford to pay costs of making 

16 oral presentations, conducting cross-examination, and making 

17 rebuttal submission in such proceeding. 

18 (B) The aggregate amount of compensation paid to 

19 all persons in any fiscal year under this subsection may 

20 not exceed $1,000,000. 

21 (d) Effective Date.— ( 1 ) The Administrator shall 

22 specify in any rule under subsection (a) the date on which 

23 it shall take effect, which date shall be as soon as feasible. 

24 (2) Section 553 (b) (B) of title 5, United States Code, 

25 shall be applicable to rules issued under subsection (a) 



108 



52 

1 notwithstanding any requirement of subsection (c) (2) or 

2 (3). 

3 IMMINENT HAZAEDS 

4 Sec. 7. (a) Definition. — An inmiinent hazard shall 

5 be considered to exist when the evidence is sufficient to show 

6 that the manufacturing, processing, distribution in com- 

7 merce, use, or disposal of a chemical substance or mixture 

8 presents an unreasonable risk of death, serious illness or 

9 serious personal injury, or serious environmental harm prior 

10 to the completion of an administrative hearing or other 

11 proceeding authorized under any other section of this Act. 

12 (b) Actions Authorized. — The Administi*ator may 

13 file an action in a United States district court — 

M ( 1 ) against an imminently hazardous chemical sub- 

15 stance or mixture for seizure of such substance or mixture, 

16 (2) against any person who manufactures, processes, 

17 distributes in commerce, uses, or disposes of such sub- 

18 stance or mixture, or 

19 (3) against both (A) such substance or mixture 

20 and (B) such person. 

21 An action under this subsection may be filed notwith- 

22 standing the existence of a rule under section 4 (a) or 6 (a) 

23 or an order under section 5(e) and notwithstanding the 

24 pendency of any administrative or judicial proceeding under 

25 any provision of this Act. 



109 



53 

1 (c) Jurisdiction of Court — (1) The United 

2 States district court in which an action under subsection (b) 

3 is brought shall have jurisdiction to grant such temporary 

4 or permanent relief as may be necessary to protect against 

5 such unreasonable risk of death, serious illness or serious 

6 personal injury, or serious environmental harm presented 

7 by the chemical substance or mixture involved in such action. 

8 (2) In the case of an action under subsection (b) 

9 brought against a person who manufactures, processes, dis- 

10 tributes in commerce, uses, or disposes of a chemical substance 

11 or mixture, the relief authorized by paragraph ( 1 ) may in- 

12 elude the issuance of a mandatory order requiring (A) in the 

13 case of purchasers of such substance or mixture known to 

14 the defendant, notification to such purchasers of the risk as- 

15 sociated with it ; (B) public notice of such risk ; (C) recall; 

16 and (D) the replacement or repurchase of such substance 

17 or mixture. 

18 (3) In the case of an action under subsection (b) 

19 against a chemical substance or mixture, such substance or 

20 mixture may be proceeded against by process of libel for 

21 its seizure and condemnation. Proceedings in such an action 

22 shall conform as nearly as possible to proceedings in rem 

23 in admiralty. 

24 (d) Venue and Consolidation.— ( 1 ) (A) An ac- 

25 tion under subsection (b) against a person who manufac- 



110 



54 

1 tures, processes, distributes in commerce, uses, or disposes of a 

2 chemical substance or mixture may be brought in the United 

3 States District Court for the District of Cohimbia or for any 

4 judicial district in which any of the defendants is found, 

5 resides, or ti'ansacts business; and process in such an action 

6 may be served on a defendant in any other district in which 

7 such defendant resides or may be found. An action under 

8 subsection (b) against a chemical substance or mixture 

9 may be brought in any United States district court 

10 within the jurisdiction of which the substance or mixture 

11 is found. 

12 (B) In determining the judicial district in whigh an 

13 action may be brought under subsection (b) in instances in 

14 which such action may be brought in more than one judicial 

15 district, the Administrator shall take into account the con- 

16 venience of the parties. 

17 (C) Subpoenas requiring attendance of witnesses in 

18 an action brought under subsection (b) may run into any 

19 judicial district. 

20 (2) Whenever proceedings under subsection (b) in- 

21 volving the same type of chemical substances or mixtures 

22 are pending in courts in two or more judicial districts, 

23 they shall be consolidated for trial by order of any 

24 such court upon application reasonably made by any party 

25 in interest, upon notice to all parties in interest. 



Ill 



55 

1 (e) Action Under Section 6 — Where appropriate, 

2 concurrently with the filing of an action under subsection (b) 

3 or as soon thereafter as may be practicable, the Administra- 

4 tor shall -initiate a proceeding for the promulgation of a rule 

5 under section 6 (a) . 

6 (f) Representation— Notwithstanding any other 

7 provision of law, in any action under subsection (b) , the 

8 Administrator may direct attorneys of the Environmental 

9 Protection Agency to appear and represent the Administra- 
10 tor in such an action. 



11 REPORTING AND RETENTION OF INFORMATION 

12 Sec. 8. (a) Reports.— (1) The Administrator shall 

13 promulgate rules under which — 

14 (A) each person who manufactures or processes 

15 or proposes to manufacture or process a chemical sub- 

16 stance shall maintain such records, and shall submit to 

17 the Administrator such reports, as the Administrator may 

18 reasonably require, and 

19 (B) each person who manufactures or processes or 

20 proposes to manufacture or process — 

21 (i) ^ mixture, or 

22 (ii) a chemical substance in small quantities 

23 (as defined by the Administrator by rule) solely for 

24 scientific experimentation or analysis or for chemical 



112 



56 

1 research or analysis, including sucli research or 

2 analysis for the development of a product, 

3 shall maintain records and submit to the Administrator 

4 reports but only to the extent the Administrator deter- 

5 mines the maintenance of records or submission of re- 
5 ports, or both, is necessary for the effective enforcement 

7 of the Act. 

8 For purposes of the compilation of the list of chemical 

9 substances required under subsection (b) , the Administrator 

10 shall promulgate rules pursuant to this subsection not later 

11 than 180 days after the date of the enactment of this Act. 

12 (2) The Administi'ator may require under paragraph 

13 (1) reporting with respect to the following: 

14 (A) The common name, trade name, the chemical 

15 identity, and the molecular structure and identity of each 

16 chemical substance or mixture for which such a report 

17 is required, insofar as known to the person making the 

18 report or insofar as reasonably ascertainable. 

19 (B) The categories or proposed categories of use 

20 of each such substance or mixture, insofar as known to 

21 the person making the report or insofar as reasonably 

22 ascertainable. 

23 (C) Reasonable estimates of the amount of each 

24 substance and mixture to be manufactured or processed 

25 and, insofar as known to the person making the report 



113 
57 

1 or insofar as reasonably ascertainable, a reasonable esti- 

2 mate of the amount of each such substance and mixture 

3 to be manufactured or processed for each of its categories 

4 or proposed categories of use. 

5 (I)) ^ description of the byproducts resulting from 
Q the manufacture, processing, use, or disposal of each such 
7 substance or mixture, insofar as known to die person 
3 making the report or insofar as reasonably ascertainable. 
9 (E) All existuig data concerning the environmental 

IQ and health effects of such substance or mixture, insofar 

11 as known to the person making the report or are reasou- 

12 ably ascertainable. 

13 (F) Estimates of the number of persons who will 

14 be exposed to such substance or mixture in their places 

15 of employment and the duration of such exposure, insofar 

16 as known to the person making the report or are reason- 

17 ably ascertainable. 

18 (b) Inventory.— The Administrator shall compile, 

19 keep current, and publish a Hst of each chemical substance or 

20 mixture which any person reports under subsection (a) or 

21 under section 5 (a) is manufactured or processed in the United 

22 States. The Administrator shall first publish such a list not 

23 later than 270 days after the date of the enactment of this 

24 Act. The Administrator shall not include in such list any 



114 



58 

1 chemical substance which is manufactured or processed only 

2. in small quantities (as defined by the Administrator by rule) 

3. solely for scientific experimentation or analysis or for chemi- 

4 cal research or analysis, including such research or analysis 

5 for the development of a product. 

6 (c) Kecoeds.— Any person who manufactures, proc- 

7 esses, or distributes in commerce or intends to manufacture, 

8 process, or distribute in commerce any chemical substance 

9 or mixture shall maintain records of adverse reactions to 

10 health or the environment alleged to have been caused by 

11 the substance or mixtm*e. Records of such adverse reactions 

12 to the health of employees shall be retained for 36^ years 

13 from the date such reactions were fii-st reported to or known 

14 by the person maintaining suoh records; and an}^ other 

15 record of such adverse reactions shall be retained for 5 years 

16 from the date the information contained in the records was 

17 first reported to or known by the person maintaining the 

18 records. Records .under this subsection shall include records 

19 of consumer allegations of personal injuiy or harm to health, 

20 reports of occupational disease or injury, and reports or 

21 complaints of injuiy to the environment subniitted to the 

22 manufacturer, processor, or distributor in commerce from 

23 any source. Upon request of an officer or employee duly 

24 designated by the Administrator, each person who is rc- 

25 quired to maintain records under this subsection shall permit 



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59 

1 the inspection of such records and shall submit copies of 

2 such records. 

3 (d) Health and Safety Studies— The Admlnis- 

4 trator shall promulgate r.ules under which the Administrator 

5 requires any person who manufa<itures, processes, or dis- 

6 tributes in commerce or who proposes to manufacture, proc- 

7 ess, or distribute in commerce any chemical substance or 

8 mixture to submit to the Administrator — 

9 ' (1) l^sts of health and safety studies conducted or 

10 initiated by or for such person with respect to such 

11 substance or mixture at any time or known to such 

12 person or are reasonably ascertainable, except that the 

13 Administrator may exclude certain types or categories 

14 of studies from the requirements of this subsection if he 

15 finds that submission of hsts of such studies are unneces- 

16 sary to carry out the purposes of this Act ; and 

17 (2) the Administrator may require the submission 

18 of any study contamed on a list submitted pursuant to 

19 paragraph (1) or otherwise known by such person. 

20 (e) Notice to Administeator of Unreasonable 

21 Risks. — Any person who manufactures, processes, or dis- 

22 tributes in commerce a chemical substance or mixture, and 

23 any liability insurer of such person, who obtains information 

24 which supports the conclusion that such substance or mixture 

25 causes or contributes to an unreasonable risk of mjury to 



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60 

1 health or the environment shall immediately inform the Ad- 

2 ministrator of such risk unless such person has reason to 

3 believe that the Administrator has been adequately informed 

4 of such risk. 

5 EELATIONSHIP TO OTHER FEDERAL LAWS 

6 Sec. 9. (a) Laws Not Administered by the Ad- 

7 MINISTRATOR. — ( 1 ) If the Administrator has reason to be- 

8 lieve that the manufacture, processing, distribution in com- 

9 merce, use, or disposal of a chemical substance or mixture 

10 causes or contributes to, or is likely to cause or contribute to 

11 an unreasonable risk of injury to health or the environment, 

12 and determines, in his discretion, that such risk may be 

13 prevented or reduced to a sufficient extent by action taken 

14 under a Federal law not administered by the Administra- 

15 tor, the Administrator shall request the agency which ad- 

16 ministers such law (A) to issue an order declaring whether 

17 or not the manufacture, processing, distribution in commerce, 

18 use, or disposal of such substance or mixture causes or con- 

19 tributes to or is likely to cause or contribute to such a risk, 

20 and (B) if the agency issues an order declaring that such 

21 manufacture, processing, distribution in commerce, use, or 

22 disposal respecting such substance or mixture causes or con- 

23 tributes to or is likely to cause or contribute to such a risk, 

24 to determine if such risk may be prevented or reduced to a 

25 sufficient extent by action taken under such law. Any such 



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61 

1 request shall be published in the Federal Register and shall 

2 be accompanied by a detailed statement of the information 

3 on which it is based. The agency receiving the request shall 

4 consider carefully all data submitted by the Administrator 

5 and other information available to it and shall issue an appro- 

6 priate order upon request, and shall make any resulting de- 

7 termination within such reasonable time as the Adminis- 

8 trator specifies in the request, but such time specified may 

9 not be less than 90 diays from the date the request was 

10 made. The report of an agency in response to a request made 

11 under this paragraph shall be accompanied by a detailed 

12 statement of the findings and conclusions of the agency re- 

13 specting the order and determination requested to be made, 
li (2) If the Administi'ator makes a request under para- 
15 graph (1) with respect to a chemical substance or mixture 
1(^ and the agency to which such request was made either — 

17 (A) issues an order declaring that there is no 

18 unreasonable risk of injury to health or the environment 

19 associated with such substance or mixture, or 

20 (B) initiates, within 90 days of the publication 

21 in the Federal Register of the report of the agency 

22 under paragraph ( 1 ) in response to such request, action 

23 under the law (or laws) administered by such agency 

24 to protect against such a risk, 

25 the Adnunistrator may not take any action under section 6 



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62 

1 or 7 with respect to the risk associated with such substance 

2 or mixture. Nothing contained herein shall prevent the 

3 Administrator from (A) making any subsequent request 

4 under paragraph (1) with respect to such risks or (B) to 

5 take subsequent action under this Act with respect to such 

6 risks if the requirements of this subsection are satisfied. 

7 (3) If the Administrator has initiated action under sec- 

8 tion 6 or 7 with respect to a risk of injury associated with a 

9 chemical substance or mixture which was the subject of a 

10 request made to an agency under paragraph ( 1 ) , such 

11 agency shall before taking action under the law (or laws) 

12 administered by it to protect against such risk consult with 

13 the Administrator for the purpose of avoiding duplication of 

14 Federal action against such risk. 

15 (b) Laws Administeeed BY THE Admixisteator. — 

16 The Administrator shall coordinate actions taken under this 
IT Act with actions taken under other Federal laws administered 

18 in whole or in part by the Administrator. The Administrator 

19 shall use the authorities contained in such other Federal laws 

20 to protect against any risk to health or the environment asso- 

21 ciated with a chemical substance or mixture unless the Ad- 

22 ministrator, in his discretion, determines that such risk may 

23 be more appropriately protected against under this Act. This 

24 subsection shall not be construed to relieve the Administrator 



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63 

1 of any requirement imposed on the Administrator by sucli 

2 other Federal laws. Nothing contained in this subsection shall 

3 (1) affect any final action taken under such other Federal 

4 law, or (2) in any way affect the extent to which hum;an 

5 health or the environment is to be protected under such other 

6 Federal law. 

7 (c) Occupational Safety and Health. — In exer- 

8 cising any authority under this Act, the Administrator sh^ll 

9 not, for purposes of section 4(b) (1) of the Occupational 

10 Safety and Health Act of 1970, be deemed to he exercising 

11 statutory authority to prescribe or enforce standards or regu- 

12 lations affecting occupational safety and health. 

13 (d) Coordination. — In administering this Act, the 

14 Administrator shall consult and coordinate with the Secre- 

15 tary of Health, Education, and Welfare and the heads of 

16 any other appropriate Federal executive . department or 

17 agency, any relevant independent regulatory agency, and 

18 any other appropriate instrumentality of the Federal Gov- 

19 emment for the purpose of achieving the maximum enforce- 

20 ment of this Act while imposing the least burdens of dupli- 

21 cative requirements on those subject to the Act and for other 

22 purposes. The Administrator shall report annually to the 

23 Congress on actions taken to coordinate with such other Fed- 

24 eral departments, agencies, or instrumentalites, and on 



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64 

1 actions taken to coordinate the authority under this Act with 

2 the authority granted under other Acts referred to in sub- 

3 section (b) . 

4 (e) Exception. — Nothing contained in this section shall 

5 limit any requirement of section 4, 5 (other than section 

6 5 (e) (2) ) , or 8, or rules promulgated thereunder. 

7 RESEARCH, COLLECTION, DISSEMINATION, AND 

8 UTILIZATION OF DATA 

9 Sec 10. (a) Authority.— The Administrator shall, in 

10 consultation and cooperation with the Secretary of Health, 

11 Education, and Welfare and with other heads of appropriate 

12 agencies, conduct such research and monitoring as h neces- 

13 sary to carry out the purposes of this Act. 

14 (b) Data Systems.— ( 1 ) The Administrator shall 

15 establish, administer, and be responsible for the continuing 

16 activities of an interagency committee which will (A) de- 

17 sign, establish, and coordinate an efficient and effective sys- 

18 tern, within the Environmental Protection Agency, for the 

19 collection, dissemination to other Federal agencies, and use 

20 of data submitted to the Administrator under this Act and 

21 (B) coordinate the regulation of chemical substances among 

22 Federal agencies. 

23 (2) (A) The Administrator shall, in consultation witii 

24 the Secretary of Health, Education, and Welfare and other 

25 heads of appropriate agencies, design, establish, and coordi- 



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65 

1 nate an efficient and effective system for the retrieval of toxi- 

2 cological and other scientific data which could be useful to the 

3 Administrator in carrying out the purposes of this Act. Sys- 

4 tematized retrieval shall be developed for use by all Federal 

5 and other agencies with responsibilities in the area of regula- 

6 tion or study of chemical substances and mixtures and their 

7 effect on health or the environment. 

8 (c) Grants and Contkacts.— The Administrator, in 

« 

9 consultation with the Secretary of Health, Education, and 

10 Welfare, is authorized to make grants and enter into con- 

11 tracts in order to carry out his responsibilities under this sec- 

12 tion. Contracts may be entered into under this section without 

13 regard to sections 3648 and 3709 of the Revised Statutes 
11 (31U.S:C.529,41 U.S.C.5). 

15 INSPECTIONS AND SUBPOENAS 

16 Sec. 11. (a) Inspections.— ( 1 ) For purposes of ad- 

17 ministermg this Act (including any rule or order promul- 

18 gated under this Act) the Administrator, or any representa- 

19 tive of the Admmistrator duly designated by the Administra- 

20 tor, may inspect any establishment, facility, or other premises 

21 in which chemical substances or mixtures are manufactured, 

22 processed, stored, or held before or after distribution in com- 

23 merce and any conveyance being used to transport chemical 

24 substances or mixtures in connection with distribution in com- 

25 merce. Such an inspection may only be made upon presenting 

S.3149 5 

79-313 O - 77 - 9 



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66 

1 appropriate credentials and a written notice to the owner, 

2 operator, or agent in charge of the premises or conveyance 

3 to he inspected. A separate notice shall he given for each 

4 such inspection, but a notice shall not be required for each 

5 entry made during the period covered by the inspection. 

6 Each such inspection shall be commenced and completed 

7 with reasonable promptness and shall be conducted at rea- 

8 sonable times, within reasonable limits, and in a reasonable 

9 manner. 

IQ (2) An mspection under paragraph (1) shall extend to 

11 all things within the premises or conveyance inspected (in- 

12 eluding records, files, papers, processes, controls, and facili- 

13 ties) bearing on whether the requirements of this Act appli- 

14 cable to the chemical substances or mixtures within such 

15 premises or conveyance have been comphed with. 

16 (b ) Subpoenas. — ^In carrying out his or her duties under 

17 the provisions of this Act, the Administrator may by subpoena 

18 require the attendance and testimony of witnesses and the 

19 production of reports, papers, documents, answers to ques- 

20 tions, or other infonnation that the Administrator deems 

21 advisable. Witnesses shall be paid the same fees and mileage 

22 that are paid witnesses in the courts of the United States. In 

23 the event of contumacy, failure, or refusal of any person to 

24 obey any such order, any district court of the United States 

25 in which venue is proper shall have jurisdiction to order any 



123 



,67 

1 such person to comply therewith. The faihire to ohey such 

2 order of the Court is punishable by the Court as a contempt 

3 thereof. 

4 EXPORT 

5 Sec. 12. (a) General.— (1) Except as provided in 

6 paragraph (2) and subsection (b), this Act (other than 

7 section 8) shall not apply to any chemical substance or 

8 mixture, if — 

9 (^M ^^^^ shown that such substance or mixture 

10 is being manufactured, processed, sold, or held for sale, 

11 for export from the United States, unless such substance 

12 or mixture is, in fact, manufactured, processed, or dis- 

13 tiibuted in commerce, for use in the United States, and 

14 (B) such substance or- mixture, when distributed 

15 in commerce, or any container in which it is enclosed 

16 when so distributed, bears a stamp or label stating 

17 that such substance or mixture, is intended for export. 

18 (2) Paragraph (1) shall not apply to any chemical 

19 substance or mixture if the Administrator finds that the 

20 substance or mixture will cause or contribute to an unreason- 

21 able risk of injury to the health of persons within the United 

22 States or to the environment of the United States or may 

23 cause or contribute to such risk. The Administrator may 

24 require, under section 4, testing of a chemical substance or 

25 mixture exempted from this Act by paragraph (1) to 



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68 

1 determnie whether or not such substance or mixture causes 

2 or contributes to an unreasonable risk to health within the 

3 United States or to the environment of the United States. 

4 (b) Notice. — (1) If any person exports or intends 

5 to export to a foreign country a chemical substance or mix- 

6 ture for which the submission of data is required under sec- 

7 tion 4 or 5, such person shall notify the Administrator of 

8 such exportation or intent to export and the Administrator 

9 shall furnish to the government of such country notice of the 

10 availabihty of the data (subject to section 14) submitted to 

11 the Administrator under section 4 or 5 for such substance or 

12 mixture. ^ 

13 (2) If any person exports or intends to export to a for- 

14 eign country a chemical substance or mixture for which a rule 

15 has been proposed or promulgated under section 5 or 6, or 

16 with respect to which an action is pending, or rehef has been 

17 granted, under section 7, such person shall notify the Ad- 

18 ministrator of such exportation or intent to export and the 

19 Administrator shall furnish to the government of such coun- 

20 try notice of such rule, action, or relief. 

21 ENTEY INTO CUSTOMS TERRITORY OF THE UNITED STATES 

22 Sec. 13. (a) General.— (1) The Secretary of the 

23 Treasury shall refuse entry into the customs territory of the 

24 United States (as defined in general headnote 2 to the Tariff 



125 
69 

3 Schedules of the United States) of any chemical substance or 

2 mixture offered for entry if — 

3 (^) it fails to conform with any requirement of this 

4 Act or any rule in effect thereunder, or 

5 (B) it is otherwise prohibited pursuant to this Act 
Q from bemg distributed in commerce. 

7 (2) If a chemical substance or mixture is refused 

8 entry under paragraph ( 1 ) , the Secretary of the 

9 Treasury shall notify the consignee of such entry refusal, 

10 shall not release it to the consignee, and shall cause its 

11 disposal or storage (under such regulations as the Secre- 

12 taiy of the Treasury may prescribe) if it has not been ex- 

13 ported by the consignee within 90 days from the date 

14 of receipt of notice of such refusal, except that the Secre- 

15 tary of the Treasuiy may, pending a review by the Admin- 

16 istrator of the entry refusal, release to the consignee such 

17 substance or mixture on execution of bond for the amount 

18 of the full invoice of such substance or mixture (as such 

19 value is set forth in the customs entry), together with 

20 the duty thereon. On failure to return such substance or 

21 mixture for any cause to the custody of the Secretary 

22 of the Treasury when demanded, such consignee shall be 

23 liable to the United States for liquidated damages equal 

24 to the full amount of such bond. All charges for storage, 



126 



70 

1 cartage, and labor on such substances or mixtures which 

2 are refused entry or release under this section shall be 

3 paid by the owner or consignee, and in default of such 

4 payment shall constitute a lien against any future entry 

5 made ])y such owner or consignee. Nothing contained 

6 herein shall limit any other remedy to which the United 

7 States is entitled. 

8 (b) KuLES. — The Secretary of the Treasury, after 

9 consultation with the Administrator, shall issue rules for 

10 the enforcement of subsection (a) of this section. 

11 DISCLOSURE OF DATA 

12 Sec. 14. An}^ information reported to, or otherwise 

13 obtained by, the Administrator or his representative, under 

14 this Act, shall be subject to section 552 of title 5, United 

15 States Code ; except that such infoi-mation shall be disclosed — 

16 (1) upon request, to officers or employees of the 

17 United States, in connection with their official duties 

18 (A) under laws protecting human health or the cn- 

19 vironment or (B) for specific law enforcement purposes ; 
^0 (2) to contractors with the United States and 

21 employees of such contractors if in the opinion of the 

22 Administrator sucli disclosure is necessary for the satis- 

23 factory performance by the contractor of a contract 

24 with the United States entered into on or after the date 



127 



71 

1 of enactment of this Act for the perfonnance of work 

2 in connection with this Act and under such conditions 

3 as the Administrator may specify ; 

4 (3) whenever the Administrator determines it nec- 

5 essary to protect human heahli or the environment; or 

6 (4) to any duly authorized committee of the Con- 

7 gress upon written request of such committee or any 

8 chairman thereof. 

9 PROHIBITED ACTS 

10 Sec. 15. It shall he unlawful for any person to- 
ll (1) fail or refuse to comply with- (A) an}- rule or 

12 order promulgated under section 4, (B) any requirement 

13 prescrihed hy section 5, or (C) any rule or order pro- 

14 mulgated under section 5 or 6; 

15 (2) use or dispose of a chemical suhstance or mix- 

16 ture which such person knew or had reason to know was 

17 manufactured, processed, or distrihuted in commerce in 

18 violation of section 5 or a rule or order under section 6; 

19 (3) fail or refuse to (A) estahlish or maintain rec- 

20 ords, (B) suhmit reports, notices, or other informa- 

21 lion, or (C) permit access to or copying of records, as 

22 required by this Act or a rule thereunder; or 

23 (4) fail or refuse to permit entry or inspection as 

24 required by section 11. 



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72 

2 PENALTIES 

2 Sec. 16. (a) Civil. — (1) Any person who violates 

3 a provision of section 15 of this Act shall be liable to the 

4 United States for a civil penalty in an amount not to exceed 

5 $25,000 for each such violation. Each day such a violation 
Q continues shall for purposes of this subsection constitute a 
rj separate violation of section 15. 

g (2) (A) A civil penalty for a violation of section 15 

9 shall be assessed by the Administrator by an order made on 

"I^Q the record after opportunity (provided in accordance with 

II this subparagraph) for a hearing in accordance with sec- 

-^2 tion 554 of title 5, United States Code. Before issuing such 

;i^3 an order, the Administrator shall give written notice to the 

24 person to be assessed a civil penalty under such order of the 

25 Administrator's proposal to issue such order and providing 

26 such person an opportunity to request, within 15 days 

27 of the date the notice is received by such person, such a 

28 hearing on the order. 

29 (B) In determining the amount of a civil penalty, the 
20 Administrator shall take into account the nature, circum- 
22 stances, exten', and gravity of the violation or violations 

22 and, with respect to the violator, ability to pay, effect on 

23 ability to continue to do business, any history of prior such 

24 violation.^, the degree of culpability, and such other matters 

25 as justice may require. 



129 



73 

1 (C) The Administrator may compromise, modify, or 

2 remit, with or without conditions, any civil penalty which 

3 may be imposed under this subsection. The amount of such 

4 penalty, when finally determined, or the amount agreed 

5 upon in compromise, may be deducted from any sums owed 
Q by the United States to the person charged. 

7 (3) Any pei^on who requested in accordance with 

8 paragraph (2) (A) a hearing respecting the assesment of a 

9 civil penalty and who is aggrieved by an order assessing a 

10 civil penalty may file a petition for judicial review of such 

11 order with the United States Court of Appeals for the Dis- 

12 trict of Columbia Circuit or for any other circuit in which 

13 such person resides or transacts business. Such a petition 

14 may only be filed within the 30-day period beginning on 

15 the date the order making such assessment was issued. 

16 (4) If any person fails to pay an assessment of a civil 

17 penalty after it has become a final and unappealable order, 

18 or after a court in an action brought under paragraph (3) 

19 has entered final judgment in favor of the Administrator, 

20 the Attorney General shall recover the amount assessed 

21 (plus interest at currently prevailing rates from such date) 

22 in any appropriate United States district court. In such 

23 action, the validity, amount, and ap})ropriateness of such 

24 penalty shall not be subject to review. 

25 (b) Ceiminal. — (1) Any person who knowingly or 



130 



74 

1 willfully violates any provision of section 15 shall, in addi- 

2 tion to or in lieu of a civil penalty which may be imposed 

3 under subsection (a) of this section for suoh violation, be 

4 subject upon conviction, to a fine of not more than $25,000 

5 for each day of violation, or to imprisonment for not more 

6 than 1 year, or both. 



7 (2) For purposes of paragraph (1), the term "know- 

8 ingly'* means having actual knowledge. 

9 SPECIFIC ENFORCEMENT AND SEIZURE 

10 Sec. 17. (a) Specific Enforcement.— ( 1 ) Upon 

11 application of the Administrator or the Attorney General 

12 the United States district courts shall have jurisdietion over 

13 civil actions to — 

14 (A) restrain any violation of section 15, 

15 (B) restrain any person from manufacturing or 

16 processing a chemical substance before the expiration 

17 of the period during which such manufacturing or proc- 

18 essing is prohibited under section 5, 

19 (C) restrain any person from taking any action 

20 prohibited by a requirement prescribed under section 

21 5 or 6 or rules or orders issued thereunder or, 

22 (U) direct any manufacturer or processor of a 

23 chemical substance or mixture not in compliance with 

24 any order issued under section 5 (e) or any rule issued 

25 under section 4 or 6, (i) to give notice of such fnct to 



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75 

1 distributors in commerce of such substance or mixture 

2 and, to the extent reasonably ascertainable, to other 

3 persons in possession of such substance or mixture or 

4 exposed to such substance or mixture, (ii) to give public 

5 notice of such risk of injury, and (iii) to either replace 

6 or repurchase such substance or mixture whichever 

7 the person to which the requirement is directed elects. 

8 (E) compel the taking of any action required by 

9 or under this Act. 

10 (^) ^ ^'i^'il i^^'tion described in paragraph (1) may be 

11 brought — 

12 (A) in the case of a civil action described in sub- 

13 paragraph (A) of such paragraph, in the United States 

14 district court for the judicial district wherein any act, 

15 omission, or transaction constituting a violation of sec- 

16 tion 15 occurred or wherein the defendant is found or 
1.7 transacts business, or 

18 (B) in the case of any other civil action described 

19 in such paragi'aph, in the United States district court 

20 for the judicial district wherein the defendant is found 

21 or transacts business. 

22 In any such civil action process may be served on a defend- 

23 ant in any judicial district in which a defendant resides or 

24 may be found. Sul)poenas requiring attendance of witnesses 

25 in any such action may run into any judicial district. 



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7G 

1 (b) Seizure. — Any chemical substance or mixture 

2 which was manufactured, processed, or distributed in com- 

3 merce in violation of this Act or any rule or order promul- 

4 gated under this Act shall be hable to be proceeded against, 

5 by process of libel for the seizure and condemnation of such 
Q substance or mixture in any United States district court 

7 within the jurisdiction of which such substance or mixture 

8 is found. Such proceedings shall conform as nearly as pos- 

9 sible to proceedings in rem in admiralty. 

10 PEEEMPTION 

11 Sec. 18. (a) Effect on State Law.— (1) Except 

12 as provided in paragraph (2), nothmg in this hct shall 

13 affect the authority of any State or political subdivision of a 

14 State to establish or continue in effect regulation of any 

15 chemical substance or mixture containing a chemical sub- 

16 stance or mixture. 

17 (2) Except as provided in subsection (b) — 

18 (^) if the Administrator requires by rule promul- 

19 gated under section 4 the testing of a chemical sub- 

20 stance or mixture, no State or political subdivision may, 

21 after the effective date of such mle, require the testing 

22 of such substance or mixture for purposes similar to 

23 those for which testing is required under such rule; 

24 and 



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77 

2 (B) if the Administrator prescribes a requirement 

2 under section 5 or 6 of this Act which is appUcahle to 

2 a chemical substance or mixture and which is designed 

4 to protect against a risk to heaUh or the environment 

5 associated with such substance or mixture no State or 
Q poHtical subdivision of a State may, after the effective 
rj date of such requirement, estabhsh or continue in effect 
g a requirement appHcable to such substance or mixture 
9 and designed to protect against such risk unless such 

requirement is identical to the requirement prescribed 

H by the Administrator or unless such State or political 

^2 subdivision requirement prohibits the use or distribution 

of such substance or mixture within the territorial juris- 

14 diction of the State or political subdivision. 

15 (b) Exemption— Upon apphcation of a State or 

16 political subdivision of a State, the Administi'ator may by 

17 rule exempt such State or subdivision from subsection (a) 

18 (2), undet such conditions as may be prescribed in such 

19 rule, if— 

20 (1) compliance with the requirement would not 

21 cause the substance or mixture to be in violation of the 

22 applicable requirement under this Act described in sub- 

23 section (a) (2) , and 

24 (2) the State or political subdivision requirement 



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76 

1 (A) provides a significantly higher degree of protection 

2 from such risk than tlie reqiih'ement under this Act de- 

3 scribed in suhsection (a) (2), and (B) does not, through 

4 difficulties in marketing, distribution, or other factors, 

5 unduly burden interstate commerce. 

Q JUDICIAL EE\1EW 

7 Sec. 19. (a) General.— Not later than GO days 

8 following the promulgation of any rule under this Act or an 

9 order under section 5 (e), any interested person may file a 

10 petition for judicial review of such rule or order with the 

11 United States Court of Appeals for the District of Columbia 

12 Circuit, or for the circuit in which such person resides or in 

13 which such person's principal place of business is located. 
1,1 Copies of the petition shall be forthwith transmitted by the 
15 clerk of such court to the Administi'ator and to the Attorney 
1(5 General. The Administrator shall transmit to the Attorney 

17 General, who shall file in the court, the record of the pro- 

18 ceedings on which the A(hninistrator based such rule or 

19 order as provided in section 2112 of title 28, United 

20 States Code. For purposes of this section, the term "record" 

21 means such rule or order, any transcript required of any 

22 oral presentation; any written submission of interested par- 

23 ties; and any other inforaiation which the Administrator 
21 considers to be relevant to such rule or order and with respect 
25 to which the Administrator, on or before the date of the 



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79 

1 promulgation of such rule or order, published a notice in 

2 the Federal Eegister identifying such information. 

3 (b) Additional Data. — ^If the petitioner applies to 

4 the oo^rt for leave to adduce additional data, views, or 

5 arguments, and shows to the satisfaction of the court that 

6 such additional data, views, or arguments are material and 

7 that there are reasonable gromid^ for tlie petitioner's failure 

8 to adduce such data, views, or argmnents in the proceeding 

9 before the Administrator, the coui't may order the Adminis- 

10 trator to provide additional opportunii}' for oral presentation 

11 of data, views, or arguments and for written submissions. 

12 The Administrator ma}^ modify findings or determinations 

13 upon which the rule or order, subject to review by such court 

14 was based, or make new findings or determinations by reason 

15 of the additional data, yiews, or argimients so taken and shall 

16 file s,uch modified or new findings or determinations, and the 

17 Administrator's rccoimiicndation, if any, for the modifica- 

18 tion or settmg aside of such rule or order, with the return of 

19 such additional data, views, or arguments. 

20 (c) AuTHOKiTY AND Review Standard.— ( 1 ) Upon 

21 the fiUng of a petition under subsection (a) , the court shall 

22 have jurisdiciton (A) to review the rule or order involved, 

23 in accordance with chapter 7 of title 5, United States Code, 

24 and (B) to grant appropriate relief, including interim reHef, 



136 



80 

2 as provided in such chapter, except that any rule promulgated 

2 by the Administrator under section 3(b), 5, or 6 of this 

3 Act and reviewed under this section shall be aifinned, unless 

4 the rule is not supported by substantial evidence on the record 
g taken as a whole. 

Q (2) The judgment of the court affirming or setting aside, 

fj in whole or in part, any rale or order reviewed in accordance 

g with this section shall be final, subject to review by the 

9 Supreme Court of the United States upon certiorari or certi- 
fication, as provided in section 1254 of title 28, the United 

II States Code. 

22 (3) The judgment of the court in an action brought 

23 pursuant to subsection (a) may include an award of costs 

14 of suit and reasonable fees for attorneys and expert witnesses 

15 if the court determines that such an award is appropriate. 
IQ The Supreme Court of the United States in its decision on a 

17 review of a judgment in such an action may provide for the 

18 award of costs of suit and reasonable fees for attorneys if the 

19 court determines that such an award is appropriate. 

20 (d) Other Remedies. — The remedies provided in this 

21 section shall be in addition to and not in lieu of any other 

22 remedies provided by law. 

23 citizen's civil action 

24 Sec. 20. (a) In General.— Except as provided in 

25 subsection (b) , any person may commence a civil action — 



137 



81 

1 (1) against any person (includmg (A) the United 

2 States, and (B) any other governmental instrumentality 

3 or agency to the extent permitted by the eleventh amend- 

4 ment to the Constitution) who is alleged to be in viola- 

5 tion of this Act or any rule or order f)rescribed under 

6 section 4, 5, or 6 (a) to restrain such violation, or 

7 (2) against the Administrator to compel the A(i- 

8 ministrator to perform any act or duty under this Act 

9 which is not discretionary. 

10 Any civil action under paragraph (1) shall be brought in the 

11 district court of the United States for the district in which 

12 the alleged violation occurred or in which the defendant 

13 resides or in which the defendant's principal place of busi- 

14 ness is located. Any action brought under paragraph (2) 

15 shall be brought in the district court for the District of Colum- 

16 bia, or the United States district court for the judicial district 

17 in which the plaintiff is domiciled. The district courts shall 

18 have jurisdiction over suits brought under this section, with- 

19 out regard to the amount in controversy or the citizenship of 

20 the parties. In any civil action under this subsection, process 

21 may be served on a defendant in any judicial district in which 

22 the defendant resides or may be found and subpoenas for 

23 witnesses may run into any judicial district. 

24 (b) Limitation.— No civil action may be com- 

25 menced — 

S, 3149—6 



79-313 O - 77 - 10 



138 



82 

1 (1) under subsection (a) (1) to restrain a viola- 

2 tion of this Aet or rule or order under this Act — 

3 (A) before the expiration of sixty days after 

4 the plaintiff has given notice of such violation (i) 
^ to the Administrator, and (ii) to the person who 
g is alleged to have committed such violation, or 

-tjf (B) if Administrator (or Attorney General 

g. on hig behalf) has commenced and is diligently 

g prosecuting a civil action in a court of the United 

2Q States to require comphance with this Act or such 

j2 rule, but if such action is commenced after the giv- 

j2 iug of notice, any person giving such notice may 

j3 intervene as a matter of right in such action ; or 

14 (2) under subsection (a) (2) before the expira- 

15 tion of 60 days after the plaintiff has given notice 

16 to the Administrator of the alleged failure of the Ad- 

17 ministrator to perform an act or duty which is the basis 

18 for such action or, in the case of an action under such 

19 subsection for the failure of the Administrator to file an 

20 action under section 7, before the expiration of 10 days 

21 after such notification. 

22 N^otice under this subsection shall be given in such manner 

23 as the Administrator shall prescribe by rule. 

24 (c) General.— (1) In any action under this section, 



139 



83 

1 the Administrator, if not a party, may inteiTene as a matter 

2 of right. 

3 (2) The court, in issuing any final order in any action 

4 brought pursuant to subsection (a), may award costs of suit 

5 and reasonable fees for attorneys and expert witnesses if the 

6 court determines that such an award is appropriate. Any 

7 court, in issuing its decision in an action brought to review 

8 such an order, may award costs of suit and reasonable fees 

9 for attorneys if the court determines that such an award is 

10 appropriate. 

11 (3) Nothing in this section shall restrict any right which 

12 any person (or class of persons) may have under any statute 

13 or common law to seek enforcement of this Act or any rule 

14 under this Act or to seek any other relief. 

15 (d) Consolidation. — When two or more civil actions 

16 brought under subsection (a) involving the same defendant 

17 or plaintiffs and the same issues or violations are pending 

18 in two or more judicial districts, such pending actions, upon 

19 application of such defendant or plaintiff to such actions 

20 which is made to a court in which any such action is 

21 brought, may, if such court in its discretion so decides, be 

22 consolidated for trial by order (issued after giving all parties 

23 reasonable notice and opportunity to be heard) of such court 

24 and tried in — 



140 
84 

1 ( 1 ) any district which is selected by such defendant 

2 or plaintiff and in which one of such actions is pending. 

3 (2) a district which is agreed upon by stipulation 

4 between all the parties to such actions and in which one 

5 of such actions is pending, or 

g (3) a district which is selected by the court and 

7 in which one of such actions is pending. 

8 The court issuing such an order shall give prompt notification 

9 of the order to the other courts in which the civil actions con- 

10 solidated under the order are pending. 

11 citizens' petitions 

12 Sec. 21. (a) In General. — Any person may petition 

13 the Administrator to issue a rule or order, or to take other 

14 action under this Act, the purpose of which is to protect 

15 against an unreasonable risk of injury to health or the 

16 environment. 

17 (b) Peoceduees.— ( 1 ) Such petition shall be filed in 

18 the principal office of the Administrator and shall set forth 

19 the facts which it is claimed estabhsh that such rule, order, or 

20 other action is necessary. 

21 (2) The Administrator may hold a public hearing or 

22 may conduct such investigation or proceeding as the Admin- 

23 istrator deems appropriate in order to determine whether or 

24 not such petition should be granted. 

25 (3) Within 90 days after filing of a petition de- 



141 



85 

1 _ scribed in paragraph ( 1 ) , the Administrator shall either 

2 grant or deny the petition. If the Administrator grants 

3 such petition, the Administrator shall promptly commence 

4 an appropriate proceeding to comply with such petition. If 

5 the Administrator denies such petition, the Administrator 

6 shall publish in the Federal Register the Administrator's rea- 

7 sons for such denial. 

8 (4) (A) If the Administrator denies a petition filed 

9 under this section (or if the Administrator fails to grant or 

10 deny such petition within the 90-day period), the peti- 

11 tioner may commence a civil action in a United States dis- 

12 trict court to compel the Administrator to initiate the action 

13 requested. Any such action shall be filed within 60 days 

14 after the Administrator's denial of the petition or, if the Ad- 

15 ministrator fails to grant or deny the petition within 90 

16 days after filing the petition, within 60 days after the ex- 

17 piration of the 90-day period. 

18 (B) If the petitioner can demonstrate to the satisfaction 

19 of the court, by a preponderance of the evidence in a de novo 

20 proceeding before such court, that the action requested in the 

21 petition conforms to thfe applicable requirements of this Act, 

22 the court shall order the Administrator to initiate the action 

23 requested by the petitioner. 

24 (C) The court in issuing any final order in any action 

25 brought pursuant to subparagraph (A) , may award costs of 

S. 3149—7 



142 



86 

-j^ suit and reasonable fees for attorneys and expert witnessjes 

2 if the coui't determines that such an award is appropriate, 

o Any court, in issuing its decision in an action brought to 

4 review such an order, may award costs of suit and reason- 

5 able fees for attorneys if the court determines that such an 
Q award is appropriate. 

ij (5) The remedies under this section shall be in addi- 

g tion to, and not in lieu of, other remedies provided by law. 

9 NATIONAL DEFENSE WyVIVER 

Sec. 22. The Administrator shah waive comphance 

-^l with any provision of this Act upon request of the Secretary 

22 of Defense and upon a determination by the President that 

;j^3 the requested waiver is necessary in the interest of national 

14 defense. The Administrator shall maintain a written record 

35 of the basis upon which such waiver was granted and make 

16 such record available for in camera examination when relc- 

17 vant in a judicial proceeding under this Act. Upon the is- 

18 suance of such a w^aiver, the Administrator shall publish in 

19 the Federal Register a notice tliat the waiver was granted 

20 for national defense purposes, unless, upon the request of 

21 the Secretary of Defense, the Administartor determines to 

22 omit such publication because the publication itself would 

23 be contrary to the interests of national defense, in which 

24 event the Administi-ator shall su])mit notice thereof to the 



143 



87 

2 Armed Services Committees of the Senate and the House of 

2 Representatives. 

3 EMPLOYEE PROTECTION 

4 Sec. 23. (a) Geneeal. — No employer may discharge 

5 any employee or otherwise discriminate against any em- 
Q ployee with respect to the employee's compensation, terms, 
tj conditions, or privileges of employment because the employee 
g (or any person acting pursuant to a request of the employee) 
Q has — 

(1) commenced, caused to be commenced, or is 
about to commence or cause to be commenced a pro- 

j2 ceeding under this Act; 

13 (2) testified or is about to testify in any such pro- 

14 ceeding ; or 

15 (3) assisted or participated or is about to assist or 

16 participate in any manner in such a proceeding or in 

17 any other action to carry out the purposes of this Act. 

18 (b) Remedy. — (1) Any employee who believes that 

19 he or she has been aisciiarged or otherwise discriminated 

20 against by any person in violation of subsection (a) of this 

21 section may, within 30 days after such alleged violation 

22 occurs, file (or have any person file on the employee's 

23 behalf) a complaint with the Secretary of Labor (herein- 

24 after in this section referred to as the "Secretary") alleging 



144 

88 

1 such discharge or discrimination. Upon receipt of such a 

2 complaint, the Secretary shall notify the person named in 

3 the complaint of the filing of the complaint. 

4 (2) (A) Upon receipt of a com})laiiit filed under para- 

5 graph ( 1 ) , the Secretary shall conduct an investigation of the 

6 violation alleged in the complaint. Within 30 days of the 

7 receipt of such complaint, the Secretary shall complete such 

8 investigation and shall notify in writing the complainant 

9 (and any person acting on behalf of the complainant) and 

10 the person alleged to have committed such violation of the 

11 results of the investigation conducted pursuant to this para- 

12 graph. Within 90 days of the receipt of such complaint the 

13 Secretary shall, unless the proceeding on the complaint is 

14 terminated by the Secretary on the basis of a settlement 

15 entered into by the Secretary and the person alleged to have 

16 committed such violation, issue an order either providing 

17 the relief prescribed by subparagraph (B) or denying the 

18 complaint. An order of the Secretary shall be made on the 

19 record after notice and opportunity for agency hearing. The 

20 Secretary may not enter into a settlement terminating a 

21 proceeding on a complaint without the participation and 

22 consent of the complainant. 

23 (B) If in response to a complaint filed under paragraph 

24 (1) the Secretary detemiines that a violation of subsection 



145 



89 

1 (a) of this section has occurred, the Secretary shall order (i) 

2 the person who committed such violation to take aflSrmative 

3 action to abate the violation, (ii) such person to reinstate 

4 the complainant to the complainant's former position to- 

5 gather with the compensation (including back pay) , terms, 

6 conditions, and privileges of the complainant's employment, 

7 (iii) compensatory damages, and (iv) where appropriate, 

8 exemplary damages. If such an order is issued, the Secre- 

9 tary, at the request of the complainant shall assess against 

10 the person against whom the order is issued a sum equal 

11 to the aggregate amount of all costs and expenses (including 

12 attorney's fees) reasonably incurred, as determined by the 

13 Secretary, by the complainant for, or in connection with, 

14 the bringing of the complaint upon which the order was 
35 issued. 

16 (c) Review. — (1) Any person adversely affected or 

17 aggrieved by an order issued under subsection (b) may 

18 obtain review of the order in the United States Court of 

19 Appeals for the circuit in which the violation, with respect 

20 to which the order was issued, allegedly occurred. The peti- 

21 tion for review must be filed within 60 days from the 

22 issuance of the Secretary's order. Review shall conform to 

23 chapter 7 of title 5 of the United States Code. 

24 (2) An order of the Secretary, with respect U) which 



146 



90 

1 review could have been obtained under paragraph ( 1 ) , shall 

2 not be subject to judicial review in any criminal or other 

3 civil proceeding. 

4 (d) Enforcement — ( 1 ) Whenever a person has 

5 failed to comply with an order issued under subsection (b) 

6 (2), the Secretary shall file a civil action in the United 

7 States distiict court for the district in which the violation 

8 was found to occur to enforce such order. In actions brought 

9 under this subsection, the district courts shall have jurisdic- 

10 tion to grant all appropriate relief, including injimctive relief 

11 and compensatory and exemplary damages. Civil actions 

12 brought under this subsection shall be heard and decided 

13 expeditiously. 

14 (2) Any nondiscretionary duty imposed by this section 

15 is enforceable in a mandamus proceeding brought under sec- 

16 tion 1361 of title 28, United States Code. 

17 (e) Exclusion. — Subsection (a) of this section shall 

18 not apply with respect to any employee who, acting with- 

19 out direction from the employee's employer (or any agent of 

20 the employer) , deliberately causes a violation of any require- 

21 ment of this Act. 

22 (f) Employment Effects.— (1) The Administrator 

23 shall conduct continuing evaluations of the potential loss or 

24 shifts of employment which may result from the issuance of 



147 



91 

1 any rule or order under this Act, including, where appro- 

2 priate, investigating threatened plant closures or reductions 

3 in employment allegedly resulting from such rule or order. 

4 (2) Any employee who is discharged or whose employ- 

5 ment is otherwise interrupted, or is threatened with discharge 
G or such interruption, or otherwise discriminated against by 

7 any person because of the results of an}- rule or order issued 

8 under this Aet, or a representative of such employee, may 

9 request the Administrator to conduct a full investigation of 

10 the matter. The Administrator shall thereupon investigate 

11 the matter and, at the request of any interested party, shall 

12 hold a pubhc hearing on not less than 5 days notice, and 

13 shall at such hearings require the parties, including the em- 
11 ployer involved, to present information relating to the actual 
13 or potential effect of such rule or order on employment and 

16 on any alleged discharge, interruption of employment, or 

17 other discrimination and tlie detailed reasons or justification 

18 therefor. Any such hearing shall be of record and shall be 

19 conducted in accordance with section 554 of title 5, United 

20 States Code. 

21 (3) Upon receiving the report of any such investigation, 
1:2 the Administrator shall make findings of fact as to the effect 

23 of such rule or order on employment and the alleged dis- 

24 charge, interruption of employment, or discrhnination and 



148 

92 

1 shall make such recommendations as he deems appropriate. 

2 Such report, findings, and recommendations shall be avail- 

3 able to the public. 

4 (4) Nothing in this subsection shall be construed to 

5 require the Administrator to modify or withdraw any rule or 

6 order issued under this Act. 

7 STUDIES 

8 Sec. 24. (a) Indemnification. — The General Ac- 

9 counting Office shall conduct a study of all Federal laws 

10 administered by the Administrator for the pui'pose of deter- 

11 mining whether and under what conditions, if any, indem- 

12 nification should be accorded any person as a. result of any 

13 action taken by the Administrator under any such law. The 
34 study shall — 

15 (1) include an estimate of the probable cost of any 

16 indemnification progmms which may be recommended; 

17 (2) include an examination of all viable means of 

18 financing the cost of any recommended indenmification ; 

19 and 

20 (3) be completed and submitted to Congress not 

21 less than 2 years from the date of enactment of this Act. 

22 (b) Classification, Storage, and Keteieval.— 

23 The Council on Environmental Quality, in consultation 

24 with the Administrator, the Secretary of Health, Edu- 

25 cation, and Welfare, the Secretary of Commerce, and the 



149 



93 

1 heads of otlier appropriate Federal departmeiits or agen- 

2 cies, shall coordinate a study of the feasibihty of estabUshing 

3 ( 1 ) a standard classifioation system for chemical substances 

4 and related substances, and (2) a standard means for 

5 storing and for obtaining rapid access to information re- 

6 specting such substances. A report on such study shall be 

7 completed and submitted to Congress not later than 18 

8 months after the date of the enactment of this Act. 

9 ADMINISTRATION OF ACT 

10 Sec. 25. (a) Cooperation of Federal Agencies.— 

11 Upon request by the Administrator, each Federal depart- 

12 ment and agency is authorized — 

13 (1) to make its services, personnel, and facilities 

14 available (with or without reimbursement) to the Ad- 

15 ministrator to assist the Administrator in the admin- 

16 isti*ation of this Act ; and 

17 (2) to furnish to the Administrator such informa- 

18 tion, data, estimates, and statistics, and to allow the 

19 Administrator access to all information in its possession 

20 as the Administrator may reasonably determine to be 

21 necessary for the admmstration of this Act. 

22 (b) Fees. — The Administrator may, by rule, require 

23 the payment of a reasonable fee from any person required 

24 to submit data under section 4 or 5 of this Act to de- 



150 



94 

1 fray the cost of administering this Act. Such rules shall not 

2 provide for any fee in excess of $2,500. In settiag such a fee, 

3 the Administrator shall take into account the ability to pay 

4 of the person required to submit the data and the cost to the 

5 Administrator of reviewing such data. Such rules may pro- 

6 vide for sharing such a fee in any case in which the expenses 

7 of testing are shared under section 4 or 5 of this Act. 

8 (c) Action With Respect to Categobies — ( 1 ) 

9 Any action which may be taken by the Administrator under 

10 any provision of this Act with respect to a chemical sub- 

11 stance or mixture may be taken by the Administrator in 

12 accordance with that provision with respect to a category 

13 of chemical substances or niixt,ures. Whenever the Admmis- 

14 trator takes action under a provision of this Act with respect 

15 to a category of chemical substances or mixtures, any refer- 

16 ence in this Act to a chemical substance or mixture (insofar 

17 as it relates to such action) shall be deemed to be a refer- 

18 ence to all chemical substances or mixtures in such category. 

19 (2) For purposes of paragraph (1) : 

20 (A) The term ''categoiy of chemical substances" 

21 means a group of chemical substances the members of 

22 which are similar in molecular structure, in physical, 

23 chemical, or biological properties, in use, or in mode of 

24 entrance into the human body or into the environment, 

25 or the members of which are in some other wa}^ s.iiitablc 



151 



95 

1 for classification as such for purposes of this Aot, except 

2 that such term does not mean a group of chemical sub- 

3 stances which are grouped together solely on the basis 

4 of their being new chemical substances. 

5 (B) The term ''category of mixtures" means a 

6 group of mixtures the members of which are similar in 

7 molecular sti'ucture, in physical, chemical, or biological 

8 properties, in use, or in mode of entrance into the human 

9 body or into the environment, or the members of which 

10 are in some other way suitable for classification as such 

11 for purposes of this Act. 

12 (d) Statement of Purpose and Justification. — 

13 Any proposed or final rule or order issued under this Act 

14 shall be accompanied by a statement of purpose and justifi- 

15 cation. Such a statement shall be considered part of the 

16 ''record of the proceedings" for purposes of judicial review 

17 under section 19 (a) . 

18 (e) Assistant Administrator.— The President, by 

19 and with the advice and consent of the Senate, shall appoint 

20 an Assistant Administrator for Toxic Substances of the Envi- 

21 ronmental Protection Agency. Such Assistant Administrator 

22 shall be a qualified individual who is, by reason of back- 

23 ground and experience, especially qualified to direct a pro- 

24 gram concerning the effects of chemicals on human health 

25 and the environment. Such Assistant Administrator shall be 



152 



96 

1 responsible for the collection of data, the preparation of 

2 studies, and the making of recommendations to the Adminis- 

3 trator for regulatory and other actions to carry out the 

4 purposes, and to facihtate the administration of this Act. 

5 AUTHORIZATION FOR APPROPRIATIONS 

6 Sec. 26. (a) In General.— There is authorized to be 

7 appropriated to the Administrator, for purposes of carrying 

8 out this Act, $11,100,000 for the fiscal year ending June 30, 

9 1976, $2,600,000 for the period beginning July 1, 1976 and 

10 ending September 30, 1976, and $10,100,000 for the fiscal 

11 year ending September 30, 1977. No part of the funds so 

12 authorized to be appropriated shall be used to construct any 

13 research laboratories. 

14 (b) Budget Requests.— Whenever the Administra- 

15 tor directly or indirectly submits, in connection with this 

16 Act, any budget requests, supplemental budget estimates, 

17 legislative recommendations, prepared testimony for con- 

18 gressional hearings, or comments on legislation to the Presi- 

19 dent or to the Office of Management and Budget, or per- 

20 sons acting on their behalf, the Administrator shall con- 

21 currently transmit a copy thereof to the Congress. No officer 

22 or agency of the United States shall have any authority to 

23 require the Administrator to submit budget requests or esti- 

24 mates, legislative recommendations, prepared testimony for 

25 congressional hearings, or comments on legislation relating 



153 



97 

1 to this Act to any officer or agency of the United States for 

2 approval, comments, or review, prior to the submission of 

3 such requests, estimates, recommendations, testimony, or 

4 comments to the Congress. 

5 ANNUAL REPORT 

6 Sf-C. 27. The Administrator shall prepare and submit 

7 to the President amir tUe Congress on or before January 1 of 

8 each year a comprehensive report on the administration of 

9 this Act during the preceding fiscal year. Such report shall 

10 include — 

11 (1) a list of the testing required under section 4 

12 during the year for which the repor^ is made and an 

13 estimate of the costs incurred during such year by the 
1^ persons required to perform such tests; 

1^ (2) the number of notices received during such year 

1^ under section 5, the number of such notices received dur- 
ing such year under such section for chemical substances 
and mixtures subject to a section 4 rule, and a summary 

19 of any" action taken during such year under section 5 (e) ; 

20 (3) a list of rules issued during such year under 

21 section 6; 

22 (4) a list, with a brief statement of the issues, of 

23 coni])]eted or pending' judicial or enforcement actions 
2- under this Act during such year; 



79-313 - 77 - 11 



154 



98 

1 (5) a summary of major problems encountered in 

2 the administration of this Act; and 

3 (6) such recommendations for additional legislation 

4 as the Administrator deems necessary to carry out the 

5 purposes of this Act. 



155 



Calendar No. 668 



94th Congbess \ (sii^-iTii- / Repoet 

2d Sesnon / si>.>Ait -j^ j^.^, 94-098 



TOXIC SUBSTxVXCES CONTROL ACT 



REPORT 

OF THE 

SENATE COMMITTEE ON COMMERCE 

ON 

S. 3149 
together with 
ADDITIONAL VIEWS 

TO REGULATE COMMERCE AND PROTECT HUMAN HEALTH 
AND THE ENVIRONMENT BY REQUIRING TESTING AND 
NECESSARY USE RESTRICTIONS ON CERTAIN CHEMICAL 
SUBSTANCES, AND FOR OTHER PURPOSES 



Mabch 16, 1976. — Ordered to be printed 



57-010 



U.S. GOVERNMENT PRINTING OFFICE 
WASHINGTON : 1976 



156 



CONTENTS 



Pac« 

Purpose and brief description 1 

Background and needs 3 

Description 6 

Responses to arguments 10 

Legislative background 13 

Section-by-section analysis 14 

Sec. 1. Short title and table of contents . 14 

Sec. 2. Findings, policy, and intent 14 

Sec. 3. Definitions and exclusions 14 

Sec. 4. Testing of chemical substances and mixtures 15 

Sec. 5. Premarket notification of chemical substances 17 

Sec. 6. Regulation of hazardous chemical substances and mixtures 20 

Sec. 7. Imminent hazards 21 

Sec. 8. Reporting and retention of information 21 

Sec. 9. Relationship to other laws 23 

Sec. 10. Research, collection, dissemination, and utilization of data.. 23 

Sec. 11. Inspections and subpoenas 24 

Sec. 12. Exports 24 

Sec. 13. Entry into customs territory of the United States 25 

Sec. 14. Disclosure of data 25 

Sec. 15. Prohibited acts 25 

Sec. 16. Penalties 26 

Sec. 17. Specific enforcement and seizure 26 

Sec. 18. Preemption 27 

Sec. 19. Judicial review 27 

Sec. 20. Citizen's civil action 28 

Sec. 21. Citizen's petitions : 29 

Sec. 22. National defense waiver 29 

Sec. 23. Employee protection 29 

Sec. 24. Studies ^ 30 

Sec. 25. Administration of act 30 

Sec. 26. Authorization for appropriations 31 

Sec. 27. Annual report 31 

Changes in existing law 32 

Estimated costs 32 

Record votes in Committee 32 

Text of S. 3149 as reported - 33 

Agency comments 73 

Additional views of Mr. Baker 89 

(HI) 



157 



Calendar No. 668 

<)4th Congress ) SENATE ( Report 

2d Session f (No. 94-698 



TOXIC SUBSTANCES CONTROL ACT 



March 16, 1976. — Ordered to be printed 



Mr. Magnusox, from the Committee on Commerce, 
submitted the following 

REPORT 

together with 
ADDITIONAL VIEWS 

[To accompany S. 3149] 

The Committee on Commerce having considered the bill (S. 3149) 
to regulate commerce and protect human health and the environment 
by requiring testing and necessary use restrictions on certain chemi- 
cal substances, and for other purposes, reports favorably thereon and 
recommends that the bill do pass. 

Purpose axd Brief Descriptiox 

The purpose of S. 3149 is to prevent unreasonable risks of injury 
to bealtli or the environment associated with the manufacture, process- 
ing, distribution in commerce, use, or disposal of chemical substances. 
The bill is designed to fill a number of regulatory gaps which cur- 
rently exist. They are : 

1. PREM arret review 

"Wliile certain environmental health statutes may be used to protect 
healtli and the environment from chemical substances, only pesticides, 
drugs, and food additives undergo j^remarket scrutiny prior to first 
manufacture. The Clean Air Act (77 Stat.. 392), the Federal Water 
Pollution Control Act (GO Stat. 755). the Occupational Safety and 
Health Act (84 Stat. 1590), and the Consumer Product Safety Act 
(Sf) Stat. 1207), do not provide for this type of premarket scrutiny. 

2. DIRECT REGULATION OF CHEMICALS 

While air and water laws authorize limitations on discharges and 
emissions, the Occupational Safety and Health Act authorizes the 
establishment of ambient air standards for the workplace, and the 
Consumer Product Safety Art authorizes standards with respect to 

(1) 



158 



consumer products, there are no existin^r statutes which authorize the 
direct control of industrial cliemicals themselves for their health or 
environmental effect (except section 211 of the Clean Air Act, which 
authorizes the re<xulation of fuel additives). 

^^Hiile these otlier authorities will in many cases be sufficient to 
adequately protect health and the environment, the alternative of 
preventing or regulating the use of the chemical in the first instance 
may be a far more effective way of dealing with the hazards. If 
expensive sewage treatment facilities can be avoided, for example, 
through removing dangerous materials from household and indus- 
trial wastes, the authority to do so ought to be provided. 

3. COXSIDERATION OF ALL THE RISKS 

"^Vhile individual agencies may be authorized to regulkte occu- 
pational, environmentah or direct consumer hazards with respect to 
a chemical substance, there is no agency which has the authority to 
look comprehensively at the hazards associated with the chemical. 
Existing authority allows the agencies to only look at the hazards 
within their jurisdiction in isolation from other hazards associated 
with the same chemical. The bill would grant the Environmental Pro- 
tection Agency the authority to look at the hazards in total. 

4. COLLECTION OF TEST DATA 

The committee bill also provides a mechanism whereby information 
with respect to health and environmental effects can be collected from 
manufacturers and processors of chemical substances. While other 
statutes provide regulatory authority, they do not place the responsi- 
bility for gathering information in support of the regulatory program 
squai^ly with persons who are responsible for the manufacture or 
processing of the chemical substance or mixtures. 

Specificallv, the bill provides: 

( 1 ) That manufacturers of neio ch emical suhsfances give notifi- 
cation to EPA 90 days in advance of first manufacture and that 
test data accompany that notification if required by EPA. The 
provision is not applicable to research chemicals unless EPA 
specifically includes any such chemical. 

(2) That the EPA Administrator require manufacturers to test 
or have tested those chemical substances which he determines 
may present an unreasonable risk of injury to health or the 
enviromnent or those for which significant human or environ- 
mental exposure takes place or will take place. The provision is 
applicable both to new and existing chemical substances. 

(3) Manufacturers and processors of chemical substances are 
required to maintain certain records and reports to better enable 
the Administrator to determine if unreasonable risks exist. Im- 
portantly, m.anufacturers must maintain with the Administrator 
lists of health and safety studies conducted, whether or not they 
have been conducted as a result of this legislation. The Adminis- 
trator is authorized to require the submission of any study on 
the list. 



159 



3 

(4) Citizens are authorized to bring suits to enjoin certain 
violations and to require the Administrator of EPA to perform 
his mandatory dutie.s. A citizens' petition provision is also pro- 
vided whereby citizens may receive judicial review of petitions 
to EPA which were denied or not act^d upon. 

Background and Needs 

The last century has witnessed the ev^er-accelerating growth of the 
cliemical industry. Sales now exceed $100 billion a year. This industry 
has developed a vast new array of chemicals. In fact, it is estimated 
that there are presently 2 million recognized chemical compoundb 
in existence with nearly 2r>0,000 new compounds produced each year. 
While most of these compounds will never be conmiercialized, the 
Environmental Protection Agency estimates that approximately 1,000 
new chemicals each year will find their way into the marketplace and 
subsequently into the environment through use or disposal. 

As the industry has grown, we have become literally surrounded 
by a man-made chemical environment. We utilize chemicals in a ma- 
jority of our daily activities. We continuall}' wear, wash with, inhale, 
and ingest a multitude of chemical substances. Many of these chem- 
icals are essential to protect, prolong, and enhance our lives. Yet, too 
frequently, we have discovered that certain of these chemicals present 
lethal health and environmental dangers. 

In 1971, the Council on Environmental Quality in a report entitled 
"Toxic Substances'- concluded that regulatory mechanisms to control 
toxic chemicals were ''inadequate." This report was the impetus for 
the original Toxic Substances Control Act legislation. 

After 15 days of hearings and extensive analysis over the last 5 
years, the Toxic Substances Control Act has evolved into a compre- 
hensive measure to protect the public and the environment from ex- 
posure to hazardous chemicals. The legislation would assure that chem- 
icals receive careful premarket scrutiny before they are manufactured 
or distributed to the public. This provision would end the present 
situation where chemicals can be marketed without notification of any 
governmental body and without any requirement that they be tested 
for safety. Thus, this provision would no longer allow the public or the 
environment to be used as a testing ground for the safety of these 
products. 

In a recent speech supporting toxic substances control legislation, 
Russell E. Train, the Administrator of the Environmental Protec- 
tion Agency, pointed out that — 

Most Ampricans had no idea, nntil relatively recently, that they were living 
so dangerously. They had no idea that when they went to work in the morning. 
OP when they ate their breakfast— that when tliey did the things they had to do 
to earn a living and keep themselves alive and well— that when they did things 
as ordinary, as innocent and as essential to life as eat, drink, breathe or touch, 
they oouTd. in fact, be laying their lives on the line. They had no idea that, with- 
out their knowledge or consent, they were often engaging in a grim game of 
chemical roulette whose result they would not know nntil many years later. 

Dr. Train's view is a reflection of the fact that in the last few years 
the list of commonly utilized and widely dispersed chemicals that 



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4 

have been found to be potentially significant health and environmental 
dangers has been constantly growing. A partial list includes: 

(1) Kepone,. which has been implicated in causing brain damage 
and other nervous system disorders ; 

(2) vinyl chloride, arsenic, and asbestos, all found to be potentially 
extremely potent cajicer-eausing agents in man ; 

(3) mercury, lead, and other heavy metals ; 

(4) PCB's which have been found to cause liver cancer in rats and 
to have contaminated numerous fish stocks throughout the United 
States; and 

(5) fluorocarbons. propellants in aerosols and coolants in refrigera- 
tors and air-conditionei-s, suspected of depleting the Earth's ozone 
layer which protects humans from excessive ultraviolet radiation that 
can cause skin cancer. 

Furthermore, the interaction of chemical substances in some cases, 
makes these dangers multiplicative rather than additive. Dr. Irving 
Selikoff, of the Mount Sinai Medical School, for example, pointed out 
that asbestos workers who are nonsmokers do not have an appreciably 
higher lung cancer rate than the population at large. However, Dr. 
Selikoff noted that if an asbestos worker smokes, his chances of getting 
lung cancer are eight times greater than the average cigarette smoker 
and are 92 times greater than an individual who is neither an asbestos 
worker or a smoker. Thus, the risks appear to be multiplied by these 
interactions. 

Russell Peterson, Chairman of the Council on Environmental Qual- 
ity, after analyzing these chemical dangers concluded at last year's 
hearings, "Toxic substances legislation is probably the most impor- 
tant environmental legislation now before the Congress." Many doctors 
and scientists concur with Dr. Peterson noting that controlling toxic 
chemicals in the environment is one of the crucial health requirements 
facing this Xation. Dr. David Rail, Director of the National Institute 
of Environmental Health Sciences of the National Institutes of Health, 
has stated, for example : 

Recent experience with vinyl chloride, bi.schloromethyl ether, methj'Ibut.vl 
ketone, and sulphuric acid mist indicate that these compounds are not theoretical 
threats, but known causes of illness and death. Many of these compounds are 
toxic to man in relatively low concentrations. Man is assaulted by these com- 
pounds alone and in combination from multiple sources. This problem constitutes 
possiUy the major health hazard of this decade. (Italics added.) 

Cancer, which was projected to kill as many Americans in 1975 as 
all the battle deaths in Vietnam, Korea, and the Second World War 
combined, appeal's particularh^ susceptible to a preventive approach 
through control of toxic substances in the environment. The National 
Cancer Institute, for example, estimates that 60 to 90 percent of the 
cancers occurring in this country are a result of environmental con- 
taminants. Furthermore, the National Cancer Institute has plotted 
the incidence of cancer around the industrial centers of the United 
States. Almost without exception the industrial centers, where indus- 
trial chemicals are obviously found in largest concentrations, had the 
highest incidence of cancer.*^ Thus, the Toxic Substances Control Act, 
which provides authority for increased testing of chemicals for their 
cancer-causing effects, can serve as an early warning system to si(rnal 
potential dangers before products are widely dispersed and irretriev- 
able societal danger has been unleashed. 



161 



5 

Toxic chemicals have also been implicated in causing birth defects 
and genetic damage. The National Foundation-March of Dimes re- 
cently wrote to Senator Magnuson in support of toxic substances 
I legislation stating : 

I More than 200,000 infants are born with physical or mental damage feach year, 
a staggering 7 percent of all births * * * A total of 15 million Americans have 
birth defects serious enough to drastically affect their daily lives * ♦ * It is 
with alarm that our attention is drawn to some aspects of modern technology 
which work counter-productive to our aims. Each year billions of pounds of chem- 
icals which are virtually untested and unregulated are produced in industrial 
processes and used in commercial products. Exi)erience with vinylchloride has 
shown it to be a highly toxic substance which experimentally can cause cancer 
and birth detects ; but this experience cajne only with its burden of proof ou 
the public. We look now to preventative testing of toxic substances in industrial 

I production prior to manufacture or distribution as one critical means to reduce 

j exogenous causes of birth defects. 

j In order to protect against these dangers, the proposed Texic Sub- 
I stances Control Act would close a number of major regulatory gaps, 
for while certain statutes, including the Clean Air Act, the Federal 
I Water Pollution Control Act, the Occupational Safety and Health 
I Act, and the Consumer Product Safety Act, may be used to protect 
health and the environment from chemical substances, none of these 
\ statutes provide the means for discovering adverse effects on health and 
environment before manufacture of new chemical substances. Under 
these other statutes, the Government regulator's only response to 
chemical dangers is to impose restrictions after manufacture begins. 

The most effective and efficient time to prevent unreasonable risks 
to public health or the environment is prior to first manufacture. It is 
at this point that the costs of regulation in terms of human suffering, 
I jobs lost, wasted capital expenditures, and other costs are lowest. Fre- 
quently, it is far more painful to take regulatory action after all of 
tliese costs have been incurred. For example, the hazards associated with 
vinyl chloride have made headlines in recent months. Vinyl chloride 
has been implicated as causing liver cancer in industrial workei^. At the 
same time the country has grown extremely reliant on the plastics 
which are produced from the chemical. In fact, 1 percent oi our gross 
national product is associated with the \anyl chloride industry. Obvi- 
ously, it is far moi-e difficult to take regulatory action against this 
chemical now, than it would have been had the dangers been known 
earlier when alternatives could have been developed and polyvinyl 
chloride plastics not become such an intrinsic pait of our way of life 
in this country. 

The proposed Toxic Substances Control Act also provides a far more 
effective mechanism to protect against dangerous chemical materials 
contained in consumer and industrial products. While air and water 
pollution laws authorize limitations on discharges and emission and 
the Occupational Safet v and Health Act authorizes workplace ambient 
standards, there are no statutes (except the fuel additives provisions of 
the Clean Air Act ) which authorize the direct control of such chem- 
icals for their health or environmental effects. 

The regulation of the discharge of excessive levels of mercury into 
the environment is an example of the need for such controls. Recently, 
there has been growing concern about mercury pollution due to indus- 
trial discharges. Yet, testimony has indicated that an even greater 



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6 

threat of pollution may be posed by the presence of mercury in such 
consumer products as paint, home thermometers, spon^s, and a variety 
of other products. Industrial pollution often can be pinpointed and cor- 
rective action rapidly taken ; however, it is nearly impossible to prevent 
an individual householder from disposing of products containing toxic 
substances either down the drain or out with the garbage. While many 
dangerous materials can be removed from municipal sewage, many 
others cannot, therefore, it seems far more prudent to provide authority 
to limit the amounts of dangerous materials in consumer products than 
to allow them to escape into a municipal sewage plant or to vainly ask 
the householder not to dispose of them. A prime purpose of the pro- 
posed Toxic Substances Control Act is to provide authority for such 
regulatory controls. 

Another important provision would provide regulators timely access 
to information regarding health and safety studies concerning chem- 
icals covered by the Act. The importance of this provision was demon- 
strated in hearings of the Subcommittee on the Environment of the 
Senate Commerce Committee, where witnesses made detailed allega- 
tions that certain groups within the chemical industry had knowledge 
of the cancer-causing potential of vinyl chloride well in advance of 
the time that this information was released to the Government or the 
public. Similar charges were made that data was suppressed which 
suggested that industrial workers exposed to the chemical BCME 
were experiencing unusually high lung cancer rates. This legislation 
will provide the authority for EPA to gather this kind of information 
with respect to existing studies as well as studies which may be begun 
in the future. 

The tim^ has passed where human health and the environment is 
protected only after serious injury has occurred. As Russell Train has 
stated: 

It is time we started putting chemicals to the test, not people. It is time we 
gave the people of this country some reason to believe that every time they take 
a breath or eat or drink or touch, they are not taking their life into their hands. 

The Committee bill, which contains provisions to regulate chemical 
hazards, will help provide this needed assurance. 

Description 

1. testixg of chemical stjbstances 

There are two multi-part bases under which the Administrator 
must require that testing be conducted on a cliemical substance or 
mixture. First, if the manufacturer, processing, distribution in com- 
merce, use, or disposal (a) may present an unreasonable risk, (b) there 
are insufficient data or experience upon which to judge the effects 
upon health and the environment, and (c) testing is necessary to 
develop data, the Administrator must require testing. 

Second, if the Administrator finds that the chemical substance 
or mixture may present significant human or environmental exposure 
because it is or will be produced in substantial quantities or for other 
reasons, and that the substance or mixture may perhaps present an ad- 
verse effect on health and the requirements of (b) and (c) above are 



163 



7 

met, the Administrator must require testing. The finding with respect 
to an adverse eflfect is to be presumed if the Administrator has no 
reliable data or experience available to him. 

In addition, the Administrator must consider the reasonably ascer- 
tainable costs and other burdens associated with conducting tests in 
light of the possible risks of injury to healtli or the environment. 
These findings are to be published in the Federal Register. 

An eight member Federal advisory committee is established to de- 
velop a priority list of chemicals which it recommends to the Admin- 
istrator for testing. The membei-s of the committee are made up of 
Federal officials who either have regulatory responsibility in the area 
of chemical substances or liave expertise with respect to testing needs. 

Within 12 months after the date of inclusion of a chemical substance 
or mixture on the priority list, the Administrator is required to either 
(a) initiate a rulemaking proceeding to require testing or (b) pub- 
' lish in the Federal Register his reasons for not initiating such a 
proceeding. 

2. PREM ARRET NOTIFICATIOX 

j At least 90 days prior to the first manufacture (for commercial 
purpose) of a new chemical substance, manufacturers are to give 
notice to the Administrator. The notice is to contain information with 
i respect to the identity of the substance, uses, estimates of amount to be 
f l)roduced, description of byproducts, a list of test data, and estimates 
of the number of employees who will be exposed to the substance. 

If a testing requirement applicable to the new cliemical has been 
established (see discussion of "Testing of Chemical Substances" above) 
the notification nmst be accompanied by the test data required. 

The 90-day premarket notification period may be extended by the 
Administrator for an additional 90 daj^s for good cause shown. 

During the premarket notification period, the Administrator is 
authorized to issue an order which may restrict or prohibit the manu- 
facturer of a new chemical substance on either of two bases : 

(a) that a test requirement is necessary (or should be revised 
or added to) ; or 

(b) that a restrictive rule is appropriate. 

Orders issued during the premarket notification period are to uc 
immediately effective and will trigger the appropriate rulemaking pro- 
visions under, section 6 (restrictions) or section 4 (testing require- 
ments). A pro\asion to expedite rulemaking under these provisions is 
provided. 

If the Administrator determines that orders during the premarket 
notification period are inappropriate or that action should not be 
taken under the imminent hazards authority of section 7, he must 
publish a statement of his reasons in the Federal Register. 

The premarket notification provisions would also apply to significant 
new uses of existiiig chemical substances. 

Premarket notification would not take place with respect to mix- 
tures or experimental or research chemicals unless the Administrator 
specifically includes any such chemical for purposes of the premarket 
notification. 

The Administrator is also authorized to exempt persons from 
premarket notification for test marketing purposes or specially limited 



164 



8 

purposes or with respect to chemical substances which are inter- 
mediate reaction products fofmed during the manufacture of other 
chemical substances and for which there is no exposure to human 
beings or tlie environment. 

3. RESTRICTIVE AUTHORITY 

Kestrictive requirements may be prescribed for any chemical sub- 
stance or mixture which presents or is likely to present an unreasonable 
risk of injury to health or the environment. Remedies available to the 
Administrator range from outright prohibitions to simple labeling 
requirements. 

In promulgating rules, the Administrator is to consider all relevant 
factors and make findings with respect to them. Included are the 
risks to liuman beings and to the environment, the benefits of the 
substance or mixture, and the reasonably ascertainable economic 
consequences of the rule. 

The Administrator is also authorized to seek orders in the district 
courts to protect against imminent hazards. Imminent hazards are 
defined as substances or mixtures which present an unreasonable risk 
of death, serious illness, or serious pei-sonal injury, or serious environ- 
mental harm prior to the completion of an administrative hearing or 
other proceeding authorized under the bill. 

4. REPORTING AND RETENTION OF INFORMATION 

The bill authorizes the Administrator to collect information whicli 
will prove extremely valuable in gathering information necessary to 
assess and take action against chemicals causing unreasonable risks. 
Manufacturers or processors may be required to submit pertinent 
information with respect to the identity, uses, amounts produced, 
byproducts, health effects, and exposure levels of chemical substances. 

In addition, lists of health and safety studies conducted by, initiated 
by, or known to persons within the chemical industry must be sub- 
mitted to tlie Administrator. The Administrator may then require 
the submission of any study appearing on the list. This will be valu- 
able in avoiding the situations that have occurred in the past with 
chemicals like vinyl chloride and BCME where allegations have been 
made that the industry and trade associations withheld information 
which would have revealed hazards associated with these chemicals 
at a much earlier date. 

In addition, persons within the chemical industry, and liability 
insurers of these pei*sons, are required to submit any information to 
the Administrator which supports the conclusion that an unreason- 
able risk to health or the environment is presented. 

5. RELATIONS j^nP TO OTHER FEDERAL LAWS 

If an unreasonable risk may be prevented or reduced sufficiently by 
other Federal laws, the Administrator must request the agency 
administering the law to issue an order declaring whether or not 



165 



9 

such a risk is presenlod. If the agency agrees that such a risk is pre- 
sented, it must determine if the risk can be prevented or reduced 
to a sufficient extent by action taken under the law administered by it. 

If the other Federal agency issues the order declaring that there 
is no unreasonable risk or initiates action under the other law, the 
Administrator may not take action under this authority to prevent 
the unreasonable risk. 

With respect to other laws administered by the Administrator, the 
Administrator is directed to coordinate his actions with actions taken 
under those Federal laws and to use the authority contained in those 
laws unless this authority would be more appropriate. 

In order to insure that information is gathered and premarket 
notification takes place, the restriction on the Administrator's author- 
ity would not apply to section 4 (testing) , section 5 (premarket notifi- 
cation), or section 8 (reporting and information gathering). 

6. CmZEXS PARTICIPATIOX 

The bill contains a citizen's suit provision which authorizes suits 
against the Administrator where he has failed to perform a nondis- 
cretionary duty and against others who are alleged to be in violation 
of sections 4 (testing), 5 (premarket notification), or 6(a) (restrictive 
rules). The provision is modeled after similar provisions in the Safe 
Drinking Water Act (88 Stat. 1660) Consumer Product Safety Act, 
Clean Air Act, Federal Water Pollution Control Act, and Noise Con- 
trol Act. 

In addition, citizens are authorized to petition the Administrator 
to take action the purpose of which is to protect against unreasonable 
risks of injury to health or the environment. If the Administrator 
fails to take action within 90 days on such a petition, or denies it, 
judicial review of the denial or failure is authorized. After gathering 
evidence in a de novo procedure, the courts would be authorized to 
require the initiation of the action requested if the petitioner has 
shown that the action requested is justified. The citizen's petition 
provision is similar to that contained in the Consumer Product Safety 
Act. 

7. EMPLOYEE PROTECTION' 

Discrimination against any employee who participates in proceed- 
ings, testifies in a proceeding, or participates in any other action neces- 
sary to carry out the purposes of the legislation is prohibited. 

A procedure is provided whereby the Secretary of Labor would 
conduct a proceeding and may order the reinstatement of the employee 
if violations are found. 

In addition, the Administrator is required to continually evaluate 
the effects on employment which may result from the issuance of rules 
or orders under the bill. If requested by an employee whose employer 
has acted against him or her because of any rule or order issued under 
this bill, or when such actions are threatened, the Administrator is 
required to investigate the matter and to make findings of fact with 
re«^pect to such allegations. 



166 



10 

Responses to Arguments 

1. The hill does not contain excessive authority for EPA, 

In the major regulatory provisions, section 4 (relating to test re- 
quirements) and section 6 (relating to restrictive authority), the 
Administrator is directed to consider costs and benefits when deriving 
appropriate rules. 

Under section 6, the Administrator is required to make findings 
with respect to all relevant factors and to publish them in the Federal 
Register. This includes the risks to health and the environment, the 
benefits of tlie substance or mixture to be regulated, and the reasonably 
ascertainable economic consequences of the rule. 

Under section 4, the Administrator is required to consider the rea- 
sonably ascertainable costs and other burdens associated with conduct- 
ing the tests in light of the possible risks of injury to health or the 
environment and is required to publish these considerations in the 
Federal Register. 

The rulemaking provisions of sections 4 and 6 provide an additional 
means to prevent improper action by EPA. Under section 4(b) (4) the 
Administrator is required to give interested persons an opportunity 
for the oral presentation of data, views, or arguments in addition to 
the opportunity to make written submissions. 

Under the rulemaking provisions of section 6, an informal hearing 
must be provided with rights of cross-examination granted in appro- 
priate instances. 

Of course, judicial review of rules issued is available. 

Finally, section 2(c) specifically states that it is the intent of Con- 
^rress that the Administrator be reasonable and prudent in his admin- 
istration of the bill, and that he is to consider the environmental, 
economic, and social impact of actions taken thereunder. 

^. The premarJcet notification provisions are not too broad. 

If hazards are to be discovered and prevented prior to the first 
manufacture of new chemical substances or prior to the imposition of 
significant new uses of existing substances, premarket notification is an 
essential provision. 

Other alternatives to the committee bill now pending in the House 
of Representatives, would restrict premarket notification only to those 
■chemical substances for which a finding of risk could be made. Thus, 
the EPA Administrator would be placed in the position of predicting 
not only what new chemical substances might be produced, but their 
level of hazard as well. The unpredictable new chemical substance 
would be completely missed by this procedure as would those sub- 
stances for which hazards information does not exist. Thus, the pre- 
market notification provisions' of the committee bill forms the back- 
bone of the preventive aspects of health protection sought by this 
legislation. 

While the EPA Administrator must be given the authority to act 
during the premarket notification period to gather more data or to 
take appropriate restrictive action, the notification burden itself should 
not be onerous. Unless testing has been otherwise required, notification 
only consists of reporting routine information which should be in the 
Jhands of the manufacturer in the fii-st place. Included is information 



167 



11 

as to the identity of the product, categories of use, estimates of the 
amount to be produced and, insofar as reasonably ascertainaJ>le, to be 
produced for each of the categories of use, a description of byproducts, 
lists of existing test data, and estimates of the number of persons who 
will be exposed in their places of employment. 

P^stimates of the number of new chemicals to which this requirement 
will be applicable range fi*om several thousand (Manufacturing 
Chemists' Association) to around 1,000 (EPA). This is contrasted 
with registration of pesticides bv EPA, for example, which numbered 
nearly 8,000 in 1975. 

3. The Committee hill does not extensively overlap with other Federal 
authorities and authority within EPA. 

Section 9 of the Committee bill requires the Administrator of EPA 
to utilize other Federal laws which he administers unless he determines 
that the risk may be more appropriately protected against by utilizing 
this authority. The right to use this authority is an alternative that 
would be extremely important in certain instances. For example, EPA 
should bo allowed to regulate a dangerous chemical substance con- 
tained within a consumer product, rather than being required to con- 
trol it later through an effluent standard or emissions standard, which 
may be a far more inefficient and expensive method of regulation. 

This relationship must exist if this legislation is to address the issue 
of controlling industrial chemicals as a means of preventing environ- 
mental degradation as an alternative to other forms of control. 

With respect to statutes not administered by EPA, the Administra- 
tor is directed to give notice to other relevant Federal agencies if the 
risk associated with a chemical may be prevented or reduced to a suf- 
ficient extent by action taken under the other Federal laws not admin- 
istered by EPA. The other agency is required to respond to the notice 
of the Administrator, but in not less than 90 days. If the other agency 
issues an order declaring that there is no unreasonable risk of injury 
to health or the environment, or initiates appropriate action under its 
own authority, the Administrator has no authority to take restrictive 
action under this Act. 

In order to elisure that the vital premarket notification, testing, 
and reporting requirements are retained, nothing contained in the 
provision is to effect that authority or requirements. 

Finally, the Administrator of EPA is required to consult and coor- 
dinate with the Secretary of Health, Education, and Welfare, and the 
heads of other appropriate Federal agencies for the purpose of achiev- 
ing the maximum enforcement under this Act while imposing the least 
burdens of duplicative requirements. 

The entire provision is designed to minimize duplication and overlap 
in the regulation of toxic chemicals, while providing EPA with suf- 
ficient authority to alert other agencies of chemical dangers where 
those other agencies have sufficient regulator}' authority to eliminate 
these dangers. 

4. The hill minimizes hurdens on small husiness. 

The bill contains a number of provisions which provide assurance 
that small business will not be overburdened by its requirements. First, 
it should be noted that small chemical manufacturers in geneml do 



168 



12 

not synthesize large numbers of new chemicals. Synthesis of new chem- 
icals takes place primarily within the major companies which have the 
financial capability to engage in this kind of research. Therefore, most 
small chemical companies should not be subject to the premarket noti- 
fication requirements of section 5. 

There are also provisions which will serve to limit the small com- 
panies' financial obligations when testing is required. A cost-sharing 
procedure, for example, is provided where a chemical company that 
wishes to produce a chemical discovered by someone else shares the 
cost of developing the test data. One of the explicitly stated bases for 
determining how these costs are to be apportioned is the market shares 
of the company which is required to provide reimbursement. A small 
company will usually have a smaller market share and therefore the 
reimbursement requirements will be minimized. 

Also, in each case where restrictive rules are authorized, the Admin- 
istrator is required to protect a.orainst "unreasonable risks." In deter- 
mining what is an "unreasonable" risk a balancing of ri?ks and bene- 
fits is required. The effect of a rule on small business, of course, is one 
of the things that the Administrator must weigh in balancing risks 
and benefits. 

The legislation also allows the Administrator to exclude substances 
from any or all provisions of the Act, if such substa.nc^ does not pre- 
sent an unreasonable risk. The products developed by small businesses 
may be excluded by the Administrator utilizing this provisk)n if such 
risks are not presented. 

Under the rulemaking procedures of this legislation, compensation 
is available to pay attorneys' fees and other costs of representing 
persons before EPA who could not otherwise afford it. Small business- 
men could well be eligible for such help. Also an amendment accepted 
by the committee provides authority to require replacement or re- 
purchase by manufacturer or processors of banned or restricted prod- 
ucts. This provision will prevent small retailers and wholesalers from 
being saddled with large inventories of otherwise unusable products. 

5. There is precedent for the de novo procedures contained in the 
citizens' petitions provisimis and such procedures are neces- 
sary. 

The citizens' petitions provision in the legislation is analoirous to 
a provision contained in the Consumer Product Safety Act. This sec- 
tion will assure that the Environmental Protection Agency is forced 
to focus on the provisions of the bill directed at protecting health and 
the environment from the dangers of toxic chemicals. The citizens' 
petitions provision is limited to petitions "the purpose of which [are] 
to protect against an unreasonable risk of injury to health or the en- 
vironment." If a citizen can show by a preponderance of the evidence 
that the action requested in a citizen's petition conforms to the appli- 
cable requirements, then EPA should be required to initiate an action. 
It should be noted that in reviewing a denial of the citizen's petition by 
the Environmental Protection Agency the court can only require EPA 
to initate an action. The court would not be allowed in this situation 
to determine the content of a rule or outcome of such a proceeding. 

The court, if petitioned, shall conduct a de novo review of any denial 
or failure to act on a citizen's petition by the Environmental Protec- 
tion Agency. In a judicial review of the Administrator's denial of a 



169 



13 

citizen's petition or failure to act, there would be no record upon 
which the review could be based, and therefore a de novo procedure is 
essential to provide the opportunity to develop such a record. 

Tlie responsiveness of government is a critical concern and the citi- 
zens' petition provision will help to protect against lax administra- 
tion of the bill. 

6. The economic hurdens that may he imposed as a result of this legis- 
lation are not substantial particularly when considered in the 
context of the economic^ heaWuand other benefits. 

There have been widely varying estimates from the chemical in- 
dustry of the total cost to the industry of the legislation. The Dow 
Chemical Co., for example, has estimated that the legislation would 
cost the chemical industry $2 billion per year. The Manufacturing 
Chemists Association estimated tliat these costs would range from $340 
million to $1.3 billion per year. The Environmental Protection Agency, 
however, estimates that the annual total cost to the chemical industry 
from the enactment of this legislation will be far lower and will range 
from $80 to $140 million per year. 

In order to anal^^ze tlie accuracy of tliese studies, the committee re- 
quested the General Accounting Office to examine these estimates. The 
General Accounting Office leport to the committee seriously questioned 
the high estimates of the Dow and Manufacturing Chemists' Asso- 
ciation studies, and stated tliat EPA's estimates Avere more reliable 
and realistic and that the legislation, if enacted, would cost the chemical 
industry between $100 to $200 million a year. 

It is important to note that in the testing and key regulatory provi- 
sions of the legislation, it is specifically required that the Admin- 
istrator evaluate the risks and the benefits of his actions before taking 
regulatory action. Thus, costs are not to be incurred unless they are otf- 
set by benefits of at least the same magnitude. In comparing risks, 
costs, and benefits, however, it is important to recognize that one is 
weighing noncommensurates, and it is not feasible to reach a decision 
just on the basis of quantitative comparisons. The burdens of human 
suffering and premature death are extraordinary and must be given 
full consideration in such decisions. 

Legislative Background 

S. 3149 had its genesis in the 92d Congress. On February 10, 1970, 
the Administrator of tlie Environmental Protection Agency trans- 
mitted by executive message a legislative proposal which was intro- 
duced bv Senators Hart and Magnuson, by request, as S. 1478, the 
"Toxic Substances Control Act of 1971." 

Eight days of hearings were held in the 92d Congress on S. 1478 
and amendment No. 338 wliich proposed major changes in the legis- 
lation. The Senate passed the bill on May 30, 1972, following Com- 
mittee action. The House of Kep resent atives acted late in the session 
but there was insufficient time to reconcile the differences between 
the Senate and House bills. 

In the 93d Congress, S. 426 was introduced on January 18, 1973 by 
Senators Magnuson, Tunney, and Hart. Three days of hearings were 
held on S. 426 and S. 888, the Administration's bill. • 

79-313 - 77 - 12 



170 



14 

Following Committee action, the Senate passed S. 426 on July 18, 
1973. The House of Eepresentatives passed S. 426 with amendments 
in lieu of H.R. 5356 on July 23, 1973. However, as in the 92d Con- 
gress, the conference was unable to rosolv^e the differences between the 
House and Senate bills. 

In the 94th Congress, S. 776 was introduced on February 20, 1975, 
by Senators Tunney, Hart, and Magnuson. Hearings w^ere held on 
March 3, 5, 10, April 5, and October 24, 1975. 

The Subcommittee on Consumer Protection and Finance of the In- 
terstate and Foreign Commerce Committee of the House of Repre- 
sentatives reported H.R. 10318 on December 3, 1975. The Senate Com- 
mittee on Commerce met in executive session on February 3, 4, and 17, 
1976, to consider a substitute text offered by Senators Hartke, Tunney, 
and Hart which conforms quite closely to H.R. 10318. The Committee 
unanimously ordered the substitute text reported favorably with 
amendments as an original bill, S. 3149. 

Section-by- Section Analysis 

section 1 short title and table of contents 

The short title of the proposed Act is the ''Toxic Substances Control 
Act." A table of contents is provided. 

SECTION 2 — FINDINGS, POLICY, AND INTENT 

Subsection (a) puts forth congressional findings that humans and 
the environment are exposed to a large number of chemical substances 
and mixtures and that some may cause an unreasonable risk of in- 
jury to^ health or the environment. The findings also state that the 
regulation of chemical substances and mixtures in intrastate commerce 
is necessary to the effective regulation of interstate commerce in such 
substances and mixtures. 

Subsection (b) sets forth the policy of the United States that ade- 
quate data should be developed with respect to chemicals and mixtures 
and that manufacturers should have the responsibility of developing 
the data. The subsection furtlier states that adequate authority should 
exist to appropriately regulate subsances and mixtures and that 
authority should not impede or unduly create unnecessary economic 
barriers to technological innovation. 

Importantly, subsection (c) states that it is the intent of Congress 
that the Administrator "shall carry out this Act in a reasonable and 
prudent manner, and that the Administrator shall consider the environ- 
mental, economic, and social impact of any action the Administrator 
proposes to take under this Act." While this section of the bill is not 
an operative section, the intent of Congress as stated in this subsection 
should guide each action the Administrator takes under othej* sec- 
tions of the bill. 

SECTION 3 — DEFINITIONS AND EXCLUSIONS 

Subsection (a) sets forth the definitions which are used in the bill. 

Of particular importance is the definition of a "chemical substance." 
The term means any substance of a particular molecular identity in- 
cluding a combination of substances occurring as a result of a chemical 
reaction, or any element or uncombined radical. 



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15 

The term does not include any mixture, ^rhich is a combination of 
chemical substances which do not react chemically with each other and 
the combination is not the result of a chemical reaction, or combina- 
tion of chemicals occurrinof in nature. Mixtures may be addressed under 
the provisions of the Act. but is excluded from the definition of chem- 
ical substance so that automatic premarket notification does not take 
place under section 5. As the term ^'mixture'' includes "articles con- 
taining chemical substances'', the use of the latter term has been 
deleted throughout the bill. 

In addition, the term does not include pesticides, tobacco, or tobacco 
products, nuclear material (as defined in the Atomic Energ\" Act), 
firearms and ammunition (to the extent subject to taxes imposecl under 
section 4181 of the Internal Tvevenue Code), or food, drugs, cosmetics, 
or medical devices (as defined in the Federal Food, Drug, and Cos- 
metic Act). The term food also means food as defined in the Poultry 
Products Inspection Act, the Federal Meat Inspection Act, and the 
Egg Products Inspection Act. With respect to the explicit exclusion 
of nuclear materials, nothing in the bill should be construed as an im- 
plicit exclusion of such materials from related Acts which contain no 
cxplirit exclusion, such as the Federal Water Pollution Control Act. 

Subsection (b) authorizes the Administrator to exclude from cover- 
age under this Act or any provision of the Act, any substance or mix- 
ture if the Administrator determines, by rule, that an unreasonable 
risk of injury to health or the environment is not presented. The exclu- 
sion under this subsection would not apply to the imminent hazards 
authority of section 7 or the mandatory reporting of unreasonable 
risk information under section 8(e) . Rules under this subsection are to 
be promulgated in accordance with the rulemakin^r provisions of sec- 
tion 6(c) which are similar to the rulemaking provisions of the Mag- 
nuson-^f OSS Warranty Federal Trade Commi^^sion Act (89 Stat. 2183). 

Exclusions under this subsection must be carefully drawn so that 
unreasonable rislvs associated with the chemical substance or mixture 
which ma}^ occur subsequent to the time of the exclusion are avoided 
as well as risks known at the time of the exclusion. The situation must 
be avoided where i^icw unpredictable uses, for example, of a chemical 
substance, may not be properly controlled under the provisions of 
this Act because of the existence of an exclusion under this subsection. 

SECTION 4 — TESTING OF CHE^riCAL SnBSTANCES AND IMIXTURES 

Subsection (a) sets forth the conditions under which the Adminis- 
trator must require testinor of a chemical substance or mixture. 

First, if a chemical substance or mixture (a) may present an un- 
reasonable risk of injury to health or the environment, (b) there are 
insufficient data or experience to reasonably determine or predict the 
effects, and (c) testing is necessary to develop data, then the Adminis- 
trator must require testing. 

Second, if a chemical substance or mixture may present a signif- 
icant human or environmental exposure because of production in sub- 
stantial quantities or for other reasons, and the substance or mixture 
may perhaps present an adverse effect on health and the environment, 
the Administrator must require testing if the two other criteria ( (b) 
and (c) above) are also satisfied. If there is no reliable data or experi- 
ence available to the Administrator, the finding required with respect 



172 



16 

to presentation of an adverse effect on health or the environment shall 
be presumed. 

With respect to mixtures, an additional finding must be made that 
testing of components of the mixture is not a more reasonable and ef- 
ficient means of determining the effects on health and the environment. 

In requiring testing, the Administrator is to consider the reason- 
ably ascertainable costs and other burdens associated with conducting 
te^ts in light of the possible risk of injury to health or the environment 
and shall publish this information in the Federal Register. 

Of course, any judicial review of these considerations shall take 
place at the time the final rule is reviewed in accodance with section 
19. Thei* will be no separate review of these considerations as a pro- 
cedural matter separate and apart from the review of the final rule. 

Subsection (b) sets forth the requirements with respect to the con- 
tent of the testing rule under subsection (a). An illustrative list of the 
kinds of health and environmental effects for which testing may be 
required is provided. 

Tlie Administrator is required, at intervals of not less than 12 
months, to review the adequacy of the rules developed under subsection 
(a) and to make appropriate revisions, if necessary. 

Eules developed under subsection (a) shall be promulgated in ac- 
cordance with the informal rulemaking procedures of section 553 of 
title 5, United States Code. The Administrator is required to give 
interested persons an opportunity for the oral presentation of data, 
views, or argument and to make a transcript of the oral presentation. 
Any such oral presentation will be informal and not subject to many 
of the delays associated with more formal hearings. 

Subsection (c) provides an exemption from the testing requirements 
so that the submission of duplicative data may be avoided. If an 
exemption takes place, a cost sharing procedure is provided so that the 
person granted the exemption provides fair and equitable reimburse- 
ment to the person who develops the data. So that small businessmen 
do not get assessed an undue proportion of the costs, the subsection re- 
quires that among the relevant factors to be considered by the Admin- 
istrator in determining fair and equitable reimbursement, that he con- 
sider the effect on competition within the chemical industry and the 
sliare of the market for such substance or mixture of the person re- 
quired to provide i^eimbursement. Any exemptions provided under 
this subsection, or under section 5(g), are expected to be made avail- 
able to the public in accordance with the confidentiality provisions of 
section 14 without delay. The most appropriate way would be to pub- 
lish notice of the exemption in the Federal Register. 

The reimbursement period lasts from 2 years after the date of sub- 
mission or at the expiration of the period which the Administrator 
determined was necessary to develop the data, whichever is later. 

Provision is also made for the sharing of data cost which is in the 
process of being developed. 

Subsection (d) requires that the Administrator publish information 
received in response to a testing requirement and make the data avail- 
able to the public (in accordance with the Freedom of Information 
Act provisions of section 14) , within 15 days of receipt. 

Subsection (e) establishes a Federal agency advisory committee to 
advise the Administrator with respect to testing priorities. Eight 



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17 

members are provided including members from tlie Department of 
Commerce, EPA, the Department of Labor, Council on Environmen- 
tal Quality, the National Institute for Occupational Safety and Health, 
the National Institute of Environmental Health Sciences, the Na- 
tional Cancer Institute, and the National Science Foundation. The 
members of the advisory committee are those Federal officials who 
either have regulatory responsibilities in the area of chemical sub- 
stances or mixtures, or have expertise with respect to testing needs. In 
accordance with this principle, it is anticipated that the member from 
the Department of Commerce would represent the National Oceanic 
and Atmospheiic Agenc3\ or the National Bureau of Standards, or 
some other agency within the Department of Commerce which has ex- 
pertise with respect to testing needs. 

Within 12 months after tlie inclusion of a chemical on the list, the 
Administrator sliall either initiate a rulemaking under subsection (a) 
or publish reasons for not initiating the proceeding. It is expected that 
the Administrator's statement in tlie Federal Register will be specific 
and will explain in some detail why the conditions for testing under 
subsection (a) are absent. 

Subsection (f) specifies required actions of the Administrator in 
response to test data or other infoiTnation which indicates that a sub- 
stance or mixture has the potential to induce: (1) cancer; (2) gene 
mutations: or (8) birth defects. The Administrator must take appro- 
priate action under the regulatory provisions of section 5(e), 6(a). or 
7 within 180 days after the date of receipt of such data or information 
or publish in the Federal Register his finding that no unreasonable risk 
of injury is presented and his reasons for making such a finding. He is 
only required to take this action when the substance or mixture has a 
potential to induce these health effects at levels for which human ex- 
posure exists, or will exist, with appropriate safety margins. 

So that the Administrator may gear up for making these kinds of 
determinations following the date of enactment, he is not required to 
take action, or publish his reasons for failing to take action, until 2 
years after the date of enactment of the Act. 

SECTTOX 5 PREMARKET XOTIFICATIOX OF CHEMICAL SUBSTAXCES 

Subsection (a) requires that manufacturers of new chemical sub- 
stances give notice to the Administrator at least 90 days prior to the 
first manufacture of a new chemical substance. The notification is 
to be accompanied by all of the pertinent information referred to 
in section 8(a) (2) regardless of whether he has or has not otherwise 
required its submission under that section. Included would be the 
identity of the chemical substance, uses anticipated, amounts to be pro- 
duced, amounts anticipated for each category of proposed use, by- 
products, lists of existing data concerning environmental or health 
effex^ts, and estimates of the number of persons who will be exposed to 
the substance in their places of employment. If unreasonable risks are 
not presented, the Administrator is authorized to shorten the 90-day 
mandatory notification requirement. 

In addition, if the chemical substance is covered by a testing re- 
quirement under section 4(a), the manufacturer is also required to 
submit the data developed in accordance with that requirement. 



174 



18 

Subsection (c) requires that tlie information submitted be published 
in the Federal Register within 15 days of receipt, subject to the pro- 
visions relating to confidentiality under section 14. The 90-day pre- 
market notification period would begin upon publication in the 
Federal Register. 

Subsection (d) authorizes the Administrator to extend the initial 
90-day period for an additional 90 days for good cause shown. Wliile 
the majority of chemicals may be adequately screened during the ini- 
tial 90-day period, there are instances in which an additional 90 days 
may be necessary to adequately screen the substances. If a completely 
new substance is being examined, for example, more time to adequately 
review the information and take appropriate action would be neces- 
sary. Thus, if the Administrator has not had sufficient opportunity 
to review the premarket notification information, and to make a judg- 
ment as to whether further action is necessary, he would have the 
authority to postpone the manufacture of the substance for up to an 
additional 90 days. 

Subsection (e) authorizes the Administrator to issue orders during 
the premarket notification period. 

If the Administrator finds that a section 4(a) testing requirement 
should be established (or should be added to or revised) he is required 
to issue an order prohibiting or restricting the chemical substance 
pending the completion of a rulemaking proceeding under section 4(a) 
and the submission of any data required thereunder. The order is to be 
immediately effective and shall contain a proposed rule (or amend- 
ment or revision thereof) under section 4(a). 

If the Administrator finds during the premarket notification period 
that a rule is appropriate under section 6(a), he shall issue an order 
which appropriately prescribes requirements authorized under sec- 
tion 6(a). The order is to be immediately effective and must contain 
a proposed rule under section 6(a). 

The Administrator is directed to conclude the rulemaking proce- 
dures under section 4(a) or section 6(a) as expeditiously as practi- 
cable. If the oral presentation of data, views, or arguments, is 
requested under section 4(a) or the opportunity to make written sub- 
missions has been requested, the Administrator must begin this pro- 
cedure within 30 days after such request. The same is true with respect 
to a rulemaking under section 6(a) . If an informal hearing under that 
section is requested, the Administrator must comply within 30 days. 
In either case, the Administrator must affirm, modify, or revoke the 
order issued within 10 days after the conclusion of the submissions or 
oral presentation under section 4 or an informal hearing under sec- 
tion 6. 

Subsection (f ) requires the Administrator to publish in the Federal 
Register his reasons if he decides not to issue an order under subsec- 
tion (e) or to take action under the imminent hazards authority of 
section 7 during the premarket notification period. The Administra- 
tor's failure to issue such an order or take action under section 7 is 
judicially reviewable in accordance with section 19. It is anticipated 
that the Administrator's statement in the Federal Register will be 
specific and contain sufficient information explaining why there are 
no unreasonable risks which should have been protected against or a 
need for more test data. 



175 



19 

Subsection (<r) provides exemptions to avoid the submission of du- 
plicative data which is similar to the jDrocedure described under sec- 
tion 4(c) , described above. 

Subsection (h) also provides for premarket notification procedures 
with respect to significant new uses of existing chem.ical substances. 
If a new use of an existing substance has been specified by the Admin- 
istrator in accordance with this subsection, all of the premarket noti- 
fication procedures and authority during the premarket notification 
period apply to such new use of an existing substance. 

Subsection (i) creates special exemptions which authorize the Ad- 
ministrator to exempt from the premarket notification provisions per- 
sons who wish to engage in test marketing or specially limited purposes 
for chemical substances upon a showing that no unreasonable risks of 
injuiy to human health or the environment would result. Appropriate 
restrictions may be imposed by the Administrator. 

In addition, premarket notification for those new chemical sub- 
stances formed through intermediate reactions within reaction vessels 
or in other instances in which there is no exposure to human beings oi; 
the environment may be avoided through exemptions issued by the 
Administrator. 

Subsection (j) authorizes the Administrator to specify any mixture 
which may be subject to any provision of the premarket notification 
procedures. 

There are mixtures such as. adhesives, paints and inks, which can 
produce chemical substances upon end use. Chemical substances pro- 
duced upon end use of such mixtures should not be considered new 
chemical substances automatically subject to the premarket notification 
provisions of this section. Manufacture is defined under section 3(a) 
(7) to mean to "import, produce, or manufacture for commercial pur- 
poses." These types of substances would not be covered under the pre- 
market notification provisions because they are not manufactured for 
commercial purpose, per se. Similarly, minor reactions occurring in- 
cidential to the mixing process or upon storage of a mixture, such as 
the cross-linking of polymers, would not constitute a basis for subject- 
ing such mixtures to the premarket notification provisions intended 
for new chemical substances because the resulting substances are not 
manufactured for commercial purpose. 

Such chemical substances arising during the formulation, storage 
or use of such mixture should be considered as byproducts of the 
precursor substance or substances. The responsibility for reporting 
and testing such byproducts under the provisions of this legislation 
would then fall upon the manufacturer of the precursor substance. 
Of course, the Administrator may specifically subject any mixture 
to the premarket notification provisions. 

Subsection (k) specifically exempts from the premarket notification 
provisions chemical substances which are manufactured or intended 
to be manufactured in small quantities solely for scientific experimen- 
tation or analysis or for chemical research. The Administrator is au- 
thorized to include those kinds of chemical substances when they may 
result in an unreasonable risk of injury to human health or the environ- 
ment. 



176 



20 

SECTION 6 — REGULATION OF HAZARDOUS CHEMICAL SUBSTANCES AND 

MIXTURES 

Subsection (a) requires the Administrator to issue rules to protect 
against chemical substances or mixtures which present or are likely to 
present an unreasonable risk of injury to health or the environment. A 
number of remedies are available to the Administrator ranging from 
outrio^ht prohibitions to labeling requirements. A procedure is pro- 
vided whereby production, processing, and distribution quotas may be 
developed in those instances where a rule of the Administrator specifies 
a total amount that may be produced, processed, or distributed and 
for Federal supervision of any voluntary agreements that might be en- 
tered into by persons who are the object of these rules and for adequate 
protection against anticompetitive practices. 

The authority of section 6(a) is broad enough to authorize the 
control of those chemical substances or mixtures which may not be the 
sole cause of an unreasonable risk. For example, if a number of prod- 
ucts are responsible for an unreasonable risk, the Administrator 
would be authorized to move against all of them even though no single 
one of them can be shown to be the sole cause. The authority is also 
broad enough to reach those chemical substances which may enhance 
the toxic properties of other substances or mixtures through the proc- 
esses known as synergism or potentiation. 

Subsection (b) authorizes the Administrator to define the manner in 
which a substance may be manufactured or proceessed if he has good 
cause to believe that such manufacturing or proceessing causes the 
adulteration of a chemical substance. A substance is considered adul- 
terated if it contains another molecular identity, uncombined radical 
element, or any combination thereof which, through the manner in 
which it is manufactured or processed, causes or contributes to an 
unreasonable risk of injury to human health or the environment. Rules 
of this type would be developed in accordance with section 554 of title 5, 
United States Code. 

Subsection (c) requires the Administrator to consider the relevant 
factors when issuing rules under subsection (a) and to make find- 
ings with respect to them. Included are the risks presented to hu- 
mans and the environment, the benefits of the substance or mixture, 
and the reasonably ascertainable economic consequences of the rule, 
including the consideration of the effect on the national economy, in- 
novation, and public health. As is the case in other instances under the 
legislation where the costs to the chemical industry of a rule are to be 
considered, it is expected that the chemical industry w^ill come forward 
with data bearing on the actual costs of compliance. 

Findings required to be made shall be published in the Federal 
Register. As is the case with respect to section 4(a) rules, and other 
rules issued under the bill, findings of this type are not to be judicially 
reviewed as a matter sepai'ate and apart from the final mile. Thus, the 
findings published in the Federal Register are informational and will 
not become the object of a separate judicial review. 

This subsection also specifies the rulemaking procedures which are 
to be followed in promulgating subsection (a) rules. The rulemaking 
procedures are to be informal and in accordance with section 553 of 
title 5, United States Code. Interested persons are entitled to orally 
present their position and to present documentary submissions. In 



177 



21 

addition, if the Administrator determines that there are disputed issues 
of material fact, he must provide interested persons with the oppor- 
tunity to make i-ebuttal submissions and to conduct such cross-exam- 
ination as he determines to be appropriate and required for a full and 
true disclosure with respect to the issues. Appropriate procedures for 
limiting the extent of cross-examination are provided. 

The Administrator is authorized to provide compensation for rea- 
sonable attorneys fees, expert witness fees, and other costs of par- 
ticipating in rulemaking proceedings to those persons who would not 
otherwise be adequately represented in such proceedings if representa- 
tion of these interests are necessary for a fair determination or such 
persons are unable to effectively participate in the proceeding because 
such persons cannot afford to pay the cost of paiticipating. Thus, the 
provision Avill help insure that the interest of consumers, public inter- 
est organizations, and otliers are represented by tlie rulemaking pro- 
cedures of tliis section. Xo more than $1 million per year may be paid 
under the provisions of this section. 

The rulemaking procedures of this subsection are virtually identi- 
cal to those contained in the Magnuson-Moss Warranty Federal Trade 
Connnission xVct. 

Subsection (b) requires the Administrator to specify in a rule is- 
sued under subsection (a) the date on which it shall take effect, which 
date shall be as soon as feasible. The relevant provisions of the Ad- 
ministrative Procedures Act are preserved which authorize the Admin- 
istrator to waive certain notice and procedural requirements when 
these requirements are impracticable, unnecessary, or contrary to the 
public interest. 

SECTION 7 — IMMINENT HAZARDS 

Subsection (a) defines an imminent hazard to be a situation involv- 
ing an unreasonable risk of death, serious illness or serious personal 
injury, or serious environmental harm which will occur prior to the 
completion of an administrative hearing or other proceedings author- 
ized under any other section of this bill. 

Subsection (b) authorizes the district courts to take action against 
imminently hazardous chemical substances, mixtures, or articles con- 
taining the substance or mixture or against persons who manufacture, 
process, distribute in commerce, use, or dispose of these subtances, 
mixtures, or articles, or to take action against both the substance, mix- 
ture, or article and any such person. 

Subsection (c) authorizes the courts to grant such relief as may be 
necessar3\ The subsection includes a number of illustrative examples. 

Subsection (d) contains venue and consolidation provisions with 
respect to suits brought under this section. 

Subsection (e) requires the Administrator, where appropriate, to 
initiate a rulemaking under section 6(a). 

Subsection (f) authorizes the representation of the Administrator 
.by attorneys of the Environmental Protection Agency w^th respect to 
suits brought under this section. 

SECTION 8 REPORTINQ AND RETENTION OF INFORMATION 

Subsection (a) requires the Administrator to issue rules which re- 
quire each person who manufactures or processes, or proposes to man- 
ufacture or process, a chemical substance to maintain those records 



178 



22 

and to make such reports as the Administrator may reasonably re- 
quire. In addition, the Administrator is required to promulgate rules 
which require manufacturers or processors of mixtures or chemical 
substances produced in small quantities solely for scientific experi- 
mentation or analysis, or for chemical research or analysis, to main- 
tain records and to submit to the Administrator reports only to the 
extent that it is necessary for the effective enforcement of the legis- 
lation. 

This subsection also contains an illustrative list of the kind of infor- 
mation which the Administrator may require of manufacturers or 
processors of chemical substances. Included are the identity of sub- 
stances, categories or proposed categories of use, estimates of the 
amount to be produced, and estimates of the amount which will be pro- 
duced for each of its categories or proposals of use, a description of by- 
products, all existing data concerning the environmental and health 
effects of the substance or mixture, and estimates of the number of 
workers who will be exposed to the chemical substance. 

To determine which substances are new chemical substances for the 
purpose of the premarket notification provisions of section 5, sub- 
section (b) requires the Administrator to publish an inventory of 
existing chemical substances not later than 270 days after the date of 
enactment of the Act. Substances not appearing on that inventory 
will be considered new chemical substances for the purposes of sec- 
tion 5. Of course, any information the Administrator receives under 
subsection (a) with respect to chemicals proposed to be manufactured 
shall not be included in the inventory until premarket notification 
occurs. 

Subsection (c) requires persons who manufacture, process, or dis- 
tribute in commerce chemical substances, or those intending to en- 
gage in these activities, to maintain records of adverse reactions to 
health or the environment alleged to have been caused by the substance 
or mixture. These kinds of records shall be maintained for 5 years from 
the date the information was reported to the person, except that re- 
ports dealing with occupational reactions shall be retained for 30 
years. 

Subsection (d) requires persons who manufacture, process, or dis- 
tribute in commerce chemical substances or mixtures to maintain lists 
of health and safety studies conducted by them or for them with the 
Administrator. The Administrator is authorized to require the sub- 
mission of any study appearing on the list. The Administrator is au- 
thorized to exclude certain types of categories of studies if they are 
unnecessary to carry out the purposes of the Act. 

Subsection (e) requires persons who manufacture, process, or dis- 
tribute chemical substances or mixtures in commerce, and liabilit}^ 
insurers thereof, to inform the Administrator when they receive in- 
formation which su Imports the conclusion that imreasonalole risks or in- 
jurys to health or the environment are caused or contributed to by a 
substance or mixture. 

The Committee is concerned that any al1of\-atior!S of risVs or othor 
information presented to the Administrator bv employees of the chein- 
ical industry receive pro]ier attention by EPA. The situation that 
existed with respect to the Kepone plant at Hopevvell, Va., whereby 
an employee complaint to the Department of Labor allegedly was 
insufficiently attended to, should not occur. EPA should respond prop- 



179 



23 

erly to complaints received in the context of this authority, and the 
Comptroller General may be asked by the committee to oversee EPA's- 
procedures with respect to employee complaints. 

SECTION 9 — RELATIONSHIP TO OTHER LAWS 

This section is intended to minimize overlap and duplication be- 
tween this act and other Federal laws while assuring protection from 
environmental and health dangers. 

Subsection (a) deals with the action the Administrator is to take 
when he determines that a law administered by another agency could 
be used to prevent or sufficiently reduce an unreasonable risk to health 
or the environment presented bv a chemical substance or mixture. In 
such a case the Administrator is to request that agency to (1) issue 
an order declaring whether or not such a risk is presented, and (2) 
if an order is isf?ued declaring that an unreasonable risk is presented, 
to determine if tlie risk may be prevented or sufficiently reduced under 
the law administered by that agency. The acrency is to respond to a 
request from the Administrator within 90 days and publish its findings 
and conclusions in the Federal Register. 

The Administrator may not take action under sections 6 or 7 of this 
act if the agency to which the request was addressed either issues an 
order declaring tliore is no unreasonable risk or initiates action under 
the law which it administers within 90 days of the publication of its 
report. 

Subsection (b) directs the Administrator to use the authorities under 
other laws he administers to prevent or reduce risks to health or the 
environment pre<^nted by chemical substances or mixtures unless he 
determines that such risks may more appropriately be protected against 
under this act. 

Subsection (c) specifies that the exercise of authority by the Admin- 
istrator under this act shall not constitute any limitation upon the 
authority of the Occupational Safety and Health Administration to 
prescribe or enforce standards or regulations affecting occupational 
safety and health. 

Subsection (d) directs the Administrator to consult and coordinate 
his activities under this act with the Secretary of Health, Education, 
and Welfare and the heads of other appropriate Federal agencies in 
order to achieve maximum enforcement of this act while imposing the 
least burden of duplicative requirements on those subject to the act. 
The Administrator is to report annually to the Congress on these 
efforts. 

Subsection (e) specifies that nothing in this section shall limit any 
requirement of section 4, 5 (other than sec. 5(e) ), or 8, or rules pro- 
mulgated thereunder. 

SECTION 10 RESEARCH, COLLECTION, DISSEMINATION, AND UTILIZATION 

OF DATA 

Siibsecfion (r>.) directs the Administrator to conduct research and 
monitoring as is necessary to carry out the purposes of the act in 
consultation and cooperation with the Secretary of Health, Education, 
and Welfare and with other heads of appropriate Federal agencies. 

Subsection (b) directs the Administrator to establish and administer 



180 



24 

an interagency committee to (1) construct within the Environmental 
Protection Agency an efficient system for the collection, dissemination 
to other Federal agencies, and use of data submitted to the Administra- 
tor under this act, and (2) coordinate the regulation of chemical sub- 
stances among Federal agencies. In consultation with the Secretary 
of Health, Education, and Welfare and the heads of appropriate agen- 
cies, the Administrator is to design, establish and coordinate a system 
for the retrieval of toxicological and other scientific data useiPul to 
the Administrator in carrying out this Act. 

Subsection (c) authorizes the Administrator, in consultation with 
the Secretary of Health, Education, and Welfare, to make grants and 
enter into contracts to carry out his responsibilities under this section. 

SECTION 11 — ^IXSPECTIOXS AND SUBPOENAS 

Subsection (a) authorizes the Administrator or his designee to in- 
spect any establishment or facility in which chemical substances or 
mixtures are m.anufactured, processed, or stored, or any conveyance 
used to transport chemical substances or mixtures for their distribu- 
tion in commerce. Such inspections shall require the presentation of 
appropriate credentials and a written notice to the owner or agent in 
charge of the premises or conveyance to be inspected, and shall be 
conducted in a reasonable manner. An inspection shall extend to all 
things within the premises or conveyance inspected (including records, 
files, papers, processes, controls, and facilities) bearing on whether 
the requirements of this act that are applicable to the chemical sub- 
stances or mixtures within such premises or conveyance have been 
complied with. 

Subsection (b) authorizes the Administrator to require, by sub- 
poena, the attendance and testimony of witnesses and the production 
of reports, papers, documents, answers to questions, or other informa- 
tion the Administrator deems advisable. In the event of controversy, 
failure, or refusal of any person to obey such order, any district court 
of the United States in which venue is proper shall have jurisdiction 
to order any such person to comply tlierewith. Failure to obey an order 
of the court is punishable by the court as a contempt. 

SECTION 12 — EXPORTS 

Subsection (a) exempts from the provisions of this Act (other than 
sec. 8) any chemical substance, mixture or article containing a 
chemical substance, mixture or article that (1) is manufactured, proc- 
essed, sold, or held for sale solely for export from the United States, 
and (2) is labeled so as to show that it is intended for export. This 
exemption shall not apply to any substance, mixture or article that the 
Administrator finds would cause or contribute to an unreasonable risk 
to the health of persons within the United States or to the environ- 
ment of the United States. This would provide control of substances 
exported to Canada, for example, which may impact the Great Lakes 
or substances to be disposed of by ocean dumping. 

Subsection (b) requires that any person who exports or intends to 
export a chemical substance or mixture shall notify the Administrator 
of such exportation or intent to export if the chemical substance or 
mixture is one (1) for which data is required under section 4 or 5, 



181 



25 

(2) for whicli a rule has been proposed or promulgated under section 
5 or 6, or (3) with respect to which an action is pending or relief has 
been gi-anted under section 7. The Administrator shall furnish the 
appropriate information pertaining to the application of this act to 
the government of the foreign country for which the export is in- 
tended. 

SECnON 13 ^EXTRY INTO CUSTOMS TERRITORY OF THE UNITED STATES 

Subsection (a) requires the Secretary of the Treasury to refuse 
entry into the customs territory of the United States of any chemical 
substance, mixture, or article containing a chemical substance or mix- 
ture offered for entry if (1) it fails to conform with any requirement 
of this act or any rule in effect thereunder, or (2) it is otherwise pro- 
hibited pursuant to this act from being distributed in commerte. The 
subsection details the procedures the Secretary of the Treasury is to 
follow in the event of an entry refusal. 

Subsection (b) directs the Secretary of the Treasury, after con- 
sultation with the Administrator, to issue rules for the enforcement of 
subsection (a) of this section. 

SECTION 14 — DISCLOSURE OF DATA 

This section specifies that information obtained by the Adminis- 
trator under this Act shall be subject to the Freedom of Information 
Act wliich establishes the availability of information re-ceived by 
Federal officials to the public. However, this section specifies that all 
information received shall be disclosed (1) upon request, to offi- 
cers_ or employees of the United States in connection with their 
official duties under laws protecting human health or the environment 
or for specific law enforcement purposes; (2) to contractors of the 
United States when necessary in the perfomiancc of a contract; (3) 
whenever the Administrator determines it necessary to protect human 
health or the environment ; or (4) to any duly authorized committee 
of the Congress upon written request. AMiile information is not re- 
quired to be disclosed in proceedings under this Act in order to pre- 
vent parties from joining such a proceeding just to get access to data, 
the Administrator is expected to release information, as he may do 
under the Freedom of Information Act, in proceedings when it will 
be used for legitimate purposes in the proceeding. 

SECTION 15 — rROlIIBITED ACTS 

This section sets forth those acts that shall be unlawful under this 
act. Such unlawful acts are (1) failure or refusal to comply with 
any rule or order promulgated under section 4, 5, or 6 or any require- 
ment prescribed by section 5, (2) the use or disposal of a chemical sub- 
stance or mixture by such person who knew or had reason to know it 
was manufactured, processed, or distributed in commerce in violation 
of section 5 or a rule or order under section 6, (3) failure or refusal to 
maintain records, submit reports, notices, or other information, or 
permit access to or copying of records as required by this act or a rule 
thereunder, or (4) failure or refusal to permit entry or inspection 
as required by section 11. 



182 



26 

SECTION 16 — PENALTIES 

Subsection (a) provides civil penalties of up to $25,000 per day for 
any person who violates this Act. Such civil penalty shall be assessed 
by the Administrator after the opportunity for an adjudicative hear- 
ing. In determining the amount of a civil penalty, the Administrator 
shall take into account the nature, circumstances, extent, and gravity 
of the violation as well as the violator's ability to pay, his ability to 
continue to do business, his history of prior violations, and his degree 
of culpability. The Administrator may compromise, modify, or remit 
any civil penalty imposed under this subsection. 

Any person who requests an adjudicative hearing for the assessment 
of a civil penalty and is aggriev^ed by an order assessing a civil pen- 
alty may file a petition for judicial review of such order with the U.S. 
Court of Appeals for the District of Columbia Circuit or for any 
other circuit in which such person resides or transacts business. 

If any person fails to pay an assessment of a civil penalty after it 
has become a final and unappealable order, the Attorney General is 
directed to recover the amount assessed, plus interest, in any appro- 
priate district court. 

Subsection (b) provides criminal penalties of up to $25,000 per day, 
in addition to or in lieu of a civil penalty, for any person who know- 
ingly (having actual knowledge) or willfully violates this Act. 

SECTION 17 SPECinC ENFORCEMENT AND SEIZURE 

Subsection (a) grants the U.S. district courts jurisdiction over civil 
actions sought by the Administrator or Attorney General, to restrain 
violations of this Act, to compel actions required by this Act, or to re- 
quire manufacturers or processors of chemical substances or mixtures 
not in compliance Avith orders or rules issued under certain provisions 
of this Act to give notice of such fact and to either repurchase or re- 
place such substances or mixtures. Such a civil action may be brought 
in the appropriate district court. 

In the Committee's deliberations on the legislation, it was determined 
that the language of amendment No. 21 (sponsored by Senators Philip 
A. Hart, Xelson, and Percy) defining the burden a plaintiff must sus- 
tain in order to gain relief under laws administered by EPA, or relief 
sought by the Administrators, should not be incorporated in this 
committee bill. The amendment attempted to rectify a three- judge 
panel decision of the 8th circuit concerning relief sought against the 
Reserve Mining Co. As decisions reached by the courts in subsequent 
appeals are consistent with the requirements of amendment No. 21, 
the amendment is unnecessary. 

Subsection (b) makes any chemical substance or mixture manu- 
factured, processed, or distributed in commerce in violation of this Act 
•or any article containing such substance or mixture liable to seizure 
and condemnation within the jurisdiction of any district court in which 
i^ucli substance, mixture, or article is found. 

SECTION 18 — PREEMPTION 

Subsection (a) asserts that, except for certain specified limitations, 
nothing in this Act shall affect any State's authority to regulate chem- 



183 



27 

ical substances, mixtures, or any article containing such substances or 
mixtures. The limitations are (1) if the Administrator has required 
by rule the testing of a chemical substance or mixture under section 4, 
no State or political subdivision may subsequently require testing for 
purposes similar to those required under the rule, and (2) if the Ad- 
ministrator prescribes a requirement under section 5 or 6 of this act 
to protect against an unreasonable risk presented by a chemical sub- 
stance, mixture, or article containing a chemical substance or mixture, 
no State or political subdivision may subsequently regulate such sub- 
stance, mixture, or article unless the regulation is identical to that pre- 
scribed by the Administrator or unless the State or political subdivision 
bans the use or distribution of such substance, mixture, or article within 
the territorial jurisdiction of the State or political subdivision. 

Subsection (b) specifies conditions under which the Administrator 
may by rule exempt a State or subdivision from the limitations im- 
posed in subsection (a). A State or subdivision may be exemp-ted if 
their requirements would not cause a violation of tliis act, a signifi- 
cantly higher degree of protection is afforded, and undue burdens on 
interstate commerce would not result. 

SECTION 19 — JTJDICL\L REVIEW 

Subsection (a) specifies that not later than 60 days after the pro- 
mulgation of any rule under this Act or an order under section 5(e), 
any person may file a petition for judicial review of such rule. The 
Administrator shall transmit to the Attorney General, who shall 
file in the court, the record of the proceedings on which the Admin- 
istrator based such rule or order as provided in section 2112 of title 
28, United States Code. The term "record'' means such rule or order, 
any transcript required of any oral presentation, any written sub- 
mission of interested parties, and any other information the Admin- 
istrator considers relevant and with respect to which the Admin- 
istrator, on or before the date of promulgation of such rule or 
order, published a notice in the Federal Register identifying such 
information. Of course, the record need not contain written documen- 
tation of each and every widely accepted scientific principle or fact 
vrhich may support the rule or order issued. In these cases, it should 
be presumed that agency expertise is definitive so that an extensive 
record need not be developed or judicial review result with respect to 
widely accepted scientific principle. 

Subsection (b) authorizes petitioners to apply to the courts for 
leave to adduce additional data, views, or arguments. If the petitioner 
satisfies the court that such additional information would be mate- 
rial and that there are reasonable grounds for the petitioner's failure 
to adduce such information in the proceeding before the Adminis- 
trator, the court may order the Administrator to provide additional 
opportunity for oral presentation and written submissions. Upon 
|the basis of the additional information, the Administrator may 
modify the findings or determinations upon which the rule or order 
reviewed by the court was based. Modified or new findings together 
with the Administrator's recommendation, if any, for modifying or 
setting aside such rule or order shall be filed with the court. 



184 



28 

Subsection (c) grants the courts jurisdiction, upon the filing- of a 
petition under subsection (a), (1) to review the rule or order in- 
volved in accordance with chapter 7 of title 5, United States Code, 
and (2) to grant appropriate relief, including interim relief, as pro- 
vided in such chapter. This subsection explicitly states that any 
iTile promulgated by the Administrator under section 5 or 6 and re- 
viewed under this section shall be afiirmed unless the rule is not sup- 
ported by the substantial evidence on the record taken as a whole. 
Review of all other actions taken (or inaction) shall be on an "arbi- 
trary or capricious" basis in accordance with chapter 7 of title 5, 
United States Code. 

Any considerations or findings required of the Administrator in 
the process of developing a rule or order under this Act shall not be 
reviewable apart from the review of the final rule or order. 

Subsection (d) specifies that remedies provided in this section 
shall be in addition to and not in lieu of any other remedies provided 
by law. 

SECTION 2 citizen's CIVIL ACTION 

The provisions of this section are intended to provide a remedy 
if the Administrator is lax in carrying out his duties under this Act. 
Subsection (a) authorizes any person to commence a civil action 
against persons alleged to be in violation of this act or any rule pre- 
scribed under section 4 (testing), section 5 (premarket notifica- 
tion), or section 6 (restrictive rules) to restrain such violation. In 
addition, actions are authorized against the Administrator to compel 
liim to perform any duty which is not discretionary under this Act. 
Actions shall be brought in the appropriate district court. 

Subsection (b) specifies certain limitations on the announcement 
of a civil action. Xo action may be commenced before the expiration 
of a specified time period after proper notice has been given of an 
alleged violation or failure of the Administrator to perform a duty 
under this act. Also, no action may be commenced if the Administrator, 
or Attorney General on his behalf, has commxCnced and is diligently 
prosecuting a civil action to require compliance with this Act. 

Subsection (c) authorizes the Administrator to intervene in any 
civil action under this section to which the Administrator is not a 
party. The court is authorized to award costs of suit and reasonable 
fees for attorneys and expert witnesses, if appropriate. 

Nothing in this section shall restrict the right of any person under 
any statute or common law to seek enforcement of this Act, or any 
rule under this Act, or to seek any other relief. 

Subsection (d) authorizes a court, upon application of the defend- 
ant, to consolidate two or more civil actions brouglit under subsec- 
tion (a) involving the same defendant and the same issues or viola- 
tions when such actions are pending in two or more judicial districts. 

SECTION 21 CrnZEN'S PETITIONS 

This provision provides a means to initiate procedures for issuance 
of a rule or order under this act to protect against unreasonable risk 
of injury to healtli or tlie environment. Included, for example, would 
be a testing requirement under section 4(a), a restrictive rule under 



185 



29 

section 6(a) . or a modification of a section 3(b) rule which would have 
the effect of further protecting against unreasonable risks by reducing 
the extent to which a chemical substance or mixture is excluded from 
coverage under the Act. Subsection (a) authorizes any person to peti- 
tion the Administrator to issue such a rule or order. 

Subsection (b) requires the Administrator to either grant or deny 
a petition within 90 days after filing. If a petition is granted, the 
Administrator shall promptly commence an appropriate proceeding 
to comply with such petition. If a petition is denied, the Administrator 
shall publish in the Federal Register the reasons for such denial. 

If the Administrator denies a petition (or fails to act within the 
90-day period), the petitioner may commence a civil action within 60 
days, in a U.S. district court to compel the Administrator to initiate 
the action requested. Because of the absence of an adequate record for 
the court to review in such a case, the opportunity is granted to the pe- 
titioner for a judicial review based on a preponderance of the evi- 
dence in a de novo proceeding. If the petitioner can satisfy the court 
by a preponderance of the evidence in such a proceeding that the ac- 
tion requested in the petition conforms to the applicable requirements 
of this act, the court shall order the Administrator to initiate the ac- 
tion requested by the petitioner. 

SECnOX 2 2 NATIOXAL DEFENSE WAFV ER 

The Administrator is directed to waive compliance with any pro- 
vision of this Act upon request of the Secretary of Defense and upon a 
determination by the President that the requested waiver is necessary 
in the interest of national defense. 

SECTION 2 3 EMPLOYEE PROTECTION 

Subsection (a) prohibits an employer from discharging or other- 
wise discriminating against any employee because the employee, or 
any person acting pursuant to a request of the employee, participates 
or intends to participate in any way in any proceeding or action for 
the purposes of carrying out the intent of this Act. 

Any employee who believes that he or she has been discharged or 
otherwise discriminated against is authorized by subsection (b) to file 
a complaint with the Secretary of Labor within 30 days of the alleged 
violation. The Secretary is to investigate such an alleged violation and 
shall, within 90 days, issue an order either providing relief or denying 
the complaint, unless the Secretary and the person alleged to have 
committed such violation agree to a settlement. The forms of relief 
which the Secretarv can provide are prescribed in this subsection. 

Subsection (c) authorizes judicial review of an order issued under 
subsection (b) upon petition by any person adversely affected or ag- 
grieved by such order, 

Whenever a person has failed to comply with an order issued under 
subsection (b), subsection (d) directs the Secretary of Labor to file 
a civil action in the appropriate district court to enforce such action. 
In such civil actions the district courts shall have jurisdiction to grant 
all appropriate relief, including injunctive relief and compensatory 
and exemplary damages. 



S. Kept. 94-698 5 



186 



30 

Subsection (e) excludes from the protection of subsection (a) any 
employee who, acting without direction from the employee's employer 
or any agent of the employer, deliberately causes a violation of any 
reauirement of this Act. 

Subsection (f) directs the Administrator to conduct continuing 
evaluations of the potential loss or shifts of employment which may 
result from the issuance of any rule or order under this act. Any em- 
ployee who is discharged or threatened with discharge or otherwise 
discriminated against by any person because of the results of any rule 
or order issued under this act may request the Administrator to 
conduct a full investigation of the matter. The Administrator shall 
thereupon investigate the matter, and, at the request of any interested 
party, shall hold a public hearing. Upon receiving the report of any 
such investigation, the Administrator shall make findings of fact as to 
the effect of such rule or order on employment and shall make recom- 
mendations as he deems appropriate, which report, findings, and rec- 
ommendations shall be available to the public. Nothing in this subsec- 
tion shall be construed to require the Administrator to modify or with- 
draw any rule or order issued under this Act. 

SECTION 24 — STUDIES 

Subsection (a) directs the General Accounting Office to conduct a 
study of all Federal laws for the purpose of determining whether and 
under what conditions, if any, indemnification should be accorded any 
person as a result of action taken by the Administrator under any 
such law. The study shall include the probable cost and means of fi- 
nancing any recommended indemnification and be submitted to the 
Congress not less than 2 years from the date of enactment of this Act. 

Subsection (b) directs the Council on Environmental Quality, in 
consultation with the Administrator, the Secretary of Health, Edu- 
cation, and Welfare, the Secretary of Commerce, and the heads of 
other appropriate Federal agencies to coordinate a studj^ of the feasi- 
bility of establishing (1) a standard classification for chemical sub- 
stances, and (2) a standard means for storing and retrieving informa- 
tion respecting such substances. 

SECTION 2 5 ADMINISTRATION OF ACT 

Federal agencies are authorized in subsection (a) to cooperate with 
the Administrator by making their services, personnel, and facilities 
available to assist in the administration of this act and by making 
available to the Administrator information necessary for the admin- 
istration of this Act. 

Subsection (b) authorizes the Administrator to require, by rule, the 
payment of a reasonable fee, not to exceed $2,500, from any person 
required to submit data under section 4 or 5 to defray the cost of ad- 
ministering the Act. 

Subsection (c) authorizes the Administrator to take action with 
respect to categories of chemical substances or mixtures as well as in- 
dividual chemical substances or mixtures. For purposes of defining a 
category, chemical substances or mixtures may be grouped by virtue 
of similarities in their chemical structure, physical, chemical or bio- 
logical properties, use, mode of entry into the human body or environ- 



187 



31 

ment, or in some other way suitable for purposes of this Act. This 
authority is given to the Administrator to facilitate the efficient and 
effective administration of this act and is not to be used in any way 
that would frustrate the intent of any provision of this Act. Thus, 
for example, categories might be appropriately used for purposes of 
compiling the inventory of section 8(b) so that every variation in 
the distribution of a polymer chain length would not be automatically 
subject to tlie premarket notification requirement. However, categories 
are not to be used in the section 8(b) inventory so as to effectively 
provide exemptions for new chemical substances intended to be 
cOA'ered under the premarket notification provision. 

Subsection (d) specifies that any proposed or final rule or order 
issued xmder this Act shall be accompanied by a statement of purpose 
and justification. This statement shall identify the sources and pre- 
cise nature of the most important information used in deciding upon 
the rule or order and shall indicate the weight or importance the Ad- 
ministrator gave to the various elements of information in arriving 
at his decision. Such a statement shall be considered part of the "rec- 
ord of the proceedings" for purposes of judicial review under section 
19(a). 

Subsection (e) directs the President, by and with the advice and 
consent of the Senate, to appoint as Assistant Administrator of the 
Environmental Protection Agency an individual who by reason of 
background and experience is especially qualified to direct a program 
concerning the effects of chemicals on human health and the environ- 
ment. Such Assistant Administrator shall be responsible for the effi- 
cient collection and analysis of data necessary for making well-in- 
formed regulatory decisions and the development of a spectrum of 
regulatory options available to the Administrator. 

SECTION 2 6 — AUTHORIZATION FOR APPROPRIATIONS 

Subsection (a) authorizes to be appropriated to the Administrator 
for carrving out this act $11 million for the fiscal year ending June 30, 
197G; $2,600,000 for the transition quarter, July 1 to September 80, 
1976 ; and $10 million for the fiscal year ending September 30, 1977. 
No part of these funds are to be used for the construction of research 
laboratories. 

Subsection (b) requires that whenever any budget request, supple- 
mental budget request, supplemental budget estimate, legislative 
recommendation, prepared testimony for congressional hearings or 
comments on legislation relating to this act is sent to the President or 
to the Office of Management and Budget, the Administrator sliall 
concurrently transmit a copy to the Congress. This subsection further 
prohibits any officer or agency of the United States from requiring 
the Administrator to submit this information to him prior to its sub- 
mission to Congress. The provision is virtually identical to that con- 
tained in the Consumer Product Safety Act. 

SECTION 2 7 — ANNUAL REPORT 

The Administrator is required to submit to the President and the 
Congress a comprehensive annual report on the administration of this 
Act. A list of items to be included in the report is presented. 



188 



32 



Changes in Exestino Law 

No changes in existing law are made by the bill as reported by the 
Committee. 

Estimated Costs 

Pursuant to the requirements of section 252 of the Legislative Re- 
organization Act of 1970, the Committee estimates the cost of the bill 
for each of the first 5 fiscal years as follows : 

Fiscal years : Amount 

1976 $11,100,000 

Transition quarter 2, 600, 000 

1977 10,100,000 

1978 11,000,000 

1979 12,000,000 

1980 13,000,000 

The Committee knows of no cost estimates made by any Federal 
agency which differs from those tabulated above. The estimates were 
derived from information submitted by EPA. 

Kecord Votes in Committee 

1. On the motion by Senator Hartke to require that "reasonably 
ascertainable economic consequences" of section 6(a) rates be con- 
sidered, that findings be made with respect to all relevant factors 
considered, and that such findings be published in the Federal Register. 

TEAS (17) 

Magnuson Tunney 
Pastore Stevenson 
Hartke Ford 
Hart Pearson 
Cannon Baker 
Long Beall 
Moss Weicker 
Hollings Buckley 
Inouye 

NATS (1) 

i Durkin 
.2. On the motion of Senator Hartke to report the bill favorably: 



jNIagnuson 

Pastore 

Hartke ■ 

Hart. 

Cannon 

Long 

]\ross 

Hollings 

Tnouye 

Tunney 



TEAS (20) 

Stevenson 

Ford 

Durkin 

Pearson 

Griffin 

Baker 

Stevens 

Beall 

Weicker 

Buckley 



NAYS (0) 



189 



73 

Text of S. 3149, As Reported 
******* 

Agency Comments 

Ex\TROXMENTAL PROTECTION AgENCY, 

Office of the Administrator, 
Washington, D.C., June 23, 1975. 

Hon. "Warren G. Magnuson, 
Chairman^ Committee o^i Commerce, 
U.S. Senate, 
Washington, D.C. 

Dear Mr. Chairman : This is in response to your request of March 6, 
1975, for the views of the Environmental Protection Agency on S. 776, 
the Toxic Substances Control Act. 

We are in accord with the objectives of S. 776 and the general 
approach taken in the bill to control toxic substances. As we testified 
before your Subcommittee on the Environment on March 10, 1975, the 
bill contains the authorities which we believe are essential for effective 
toxic substances control legislation. We urged the enactment of toxic 
substances control legislation and indic^ated that we would have sug- 
gestions on some of the specific provisions of S. 776 when we submitted 
our report. 

We note that S. 776 contains significant improvements over some of 
the toxic substances control bills that have been before the committee 
the past 4 years. Many of thcvse improvements are consistent with past 
EPA recommendations. It is not our intention in our report by con- 
centrating on suggested revisions to the bill to detract from or fail 
to recognize the effort and improvements already eWdent in S. 776. 

We liave already stated in our testimony our objection to the pro- 
vision that would preclude tlie Administrator from forwarding any 
budget estimates, legislative proposals, comments on legislation, or 
testimony to the Office of ^lanagement and Budget prior to the trans- 
mission of these same materials to the Congress. We also stated in our 
testimony that to desigTiate by statute the specific responsibility of an 
Assistant Administrator may tend to crexite a problem of internal 
management. 

We will discuss below a number of additional areas in S. 776 where 
we have particular problems and where we believe amendments are 
in order. These proposed amendments are set out in an attachment to 



190 



74 

this letter along with a number of important additional amendments 
and brief explanations of each. We urge that all of these amendments 
be favorably considered by the committee. 

This report on S. 776, including the attached proposed amendments 
were jointly developed with the other concerned Federal departments 
and agencies and represents the views of the administration on S. 776. 

Policy of Administration 

We are proposing that the Declaration of Policy section of the bill 
include recognition of the role of this legislation in complementing and 
supplementing a number of present Federal programs that deal with 
various aspects of toxic substance control. We are also proposing that 
the general requirement of the bill for consultation and coordination 
make specific reference to this policy statement. Such amendments 
would be of great assistance in the day to day administration of this 
legislation, both by assuring due regard for the responsibilities of 
other agencies, and by helping to establish the atmosphere of coopera- 
tion and interchange which is vital to the successful operation of com- 
prehensive toxic substances legislation. 

In line with this policy, and because of the special role of the Occu- 
pational Safety and Health Act of 1970 in providing workers with 
protection from unsafe or unhealthful working conditions which may 
be created through the manufacture, distribution or use of toxic sub- 
stances, we are also proposing some language for the bill and some 
language for the committee report to assure that there will be no 
question about the respective regulatory jurisdictions of EPA and the 
Department of Labor. 

Definitions 

We are proposing that the definition of "chemical substance" be 
amended to provide the Administrator with some flexibilitv to exclude, 
in appropriate situations, certain substances from the definitions and 
thus from the requirements of the act or from particular provisions of 
the act. It would be almost impossible to draft the bills to exempt 
certain substances from the act or, as more likely the case, from certain 
provisions of the act in each situation where such is necessary. Scien- 
tific laboratory reagents are an example. Here it may very well be 
appropriate to exclude such nroducts from the testing and regulatory 
provisions, but not necessarily the reporting and adverse effects provi- 
sions when they are used by certain research or scientific laboratories: 
on the other hand, we would not likely wish to exclude high school 
laboratories from any labeling requirements. An exclusion may also be 
in order for a substance not manufactured in commercial quantities. 
An excessive burden and inconvenience to the industry or the user 
would be averted with this flexibility in the act. 

We anticipate that the Administrator would exercise his discretion 
to exclude from the definition of chemical substances most substances 
manufactured in less than commercial quantities for the purpose of 
testin.^. Thus, most substances manufactured in less than commercial 
miantities would be exempt from the testing provisions of the bill. 
The proposed amendment would however enable EPA to require 
testing in those cases where the potential threat to health and the en- 
vironment showed such testing to be necessan\ 



191 



75 

TVe are also proposing to add to the act a definition for a "new 
chemical substance.'' This is necessary in order that chemical sub- 
stances which were used in previous years for some purpose, and such 
use discontinued, do not become classified as existing chemicals, and 
thus exempt from certain requirements relating to new substances. 

Testing 

The testing provisions provide that standards for test protocols 
would be promul crated, rather than the test protocol itself. Testing 
would be required only for substances which the Administrator de- 
termines may present an unreasonable risk to health or the environ- 
ment, where there are insufficient data to conclude that such a risk 
does or does not exist, and where testing would assist in making such a 
determination. 

There is a provision in the testing requirement of the bill that we 
foresee as an undue burden upon the Administrator. While we agree 
that provision should be made for the sharing of testing costs in the 
event that there is more than one manufacturer of a substance for 
which testing is required, we are very reluctant to become involved 
in designating which manufacturer — or possibly a third party — should 
conduct the tests if the parties cannot reach an agreement. We are 
therefore recommending deletion of the provisions authorizing the 
Administrator to designate which party should do the testing. 

A further amendment we are proposing with regard to the testing 
provisions is a specific requirement that the Administrator must con- 
sider alternative methods for meeting the standards for test protocols 
proposed by a manufacturer, such as one that might be less costly or 
more effective. This would insure that industry is allowed to use the 
best test protocols in meeting the testing standards. 

Premarket screening 

We are proposing an amendment which will delete the authority in 
the bill to treat a rule proposed under section 6 during the premarket 
review period of a product as a final rule. Thus a chemical substance 
of product may be manufactured and distributed after the premarket 
review period unless a restriction is obtained under the imminent 
hazard provision of the act. The substance or product, however, re- 
mains subject to all other provisions of the act and a rule proposing 
restrictions on the substance or product may be proposed immediately 
during the premarket review period under section 6 and the rule- 
making proceedings initiated at that time. 

If it appears that the manufacture, processing, or distribution of a 
chemical substance or product will result in any unreasonable threat to 
human health or the environment prior to the completion of the rule- 
making proceedings, action may be taken to restrict or ban it under the 
imminent hazard provisions of the bill, thus preventing it from be- 
coming a threat to health or the environment. 

Quotas 

Another difficulty we have with S. 776 concerns the requirement that 
the Administrator provide for the assignment of quotas in any regu- 
lation limiting the amount of a substance which may be manufac- 
tured, imported, or distributed. The mandatory requirement of a quota 
system would make the regulatory process vastly more cumbersome 
and difficult to administer. Thus, we recommend that the quota provi- 



192 



I 



76 

sion be deleted. The act already provides that when it is necessary to 
adopt a rule with respect to a chemical substance to protect against an 
unreasonable risk, the Administrator shall select the least stringent 
requirement practicable, consistent with protection of health and the 
environment. In our view, restrictions limiting the amount of a sub- 
stance that may be manufactured would be the most stringent require- 
ment, other than a total ban, and the establishment of quotas would 
seldom be necessary. Nevertheless, we strongly recommend against be- 
coming involved in the establishment of quotas for various manufac- 
turers, even in such limited situations. 

Economic impact 

S. 776 would require that the Administrator consider a number of 
relevant factors in promulgating iiilcs with respect to a chemical sub- 
stance. We are proposing that a specific provision be added that he 
also must consider the economic impact of such action, including, but 
not limited to, consideration of the effects on business, employment, 
and the national economy. Consideration of these factors are already 
inherent in the requirement that he consider all relevant factors. This 
amendment is submitted in lieu of other proposals that have already 
been made for the mandatory preparation of detailed economic im- 
pact statements at the time a regulation is promulgated. 

Health and safety studies 

We are proposing a revision of the requirement for the submis- 
sion of health and safety studies, or lists of such studies, in order to 
provide some flexibility in this requirement. This should lessen the 
burden to industry in compiling the lists or submitting the studies, 
and to EPA in not being overburdened with information it does not 
need or cannot effectively use. The amendment would require submis- 
sion of lists of ongoing and new studies, rather than the study, with 
a right to require the submission of a given study. It would author- 
ize the Administrator to provide by regulation the types of studies 
to be included on the lists and the number of years for which prior 
studies must be listed. The amendment would also provide that a per- 
son would list studies which he knows are being made or have been 
made. 

Confidential information 

We are recommending that the confidentiality provision, section 15 
of S. 776, be amended in several respects. First, the substantive cri- 
terion for withholding data as confidential should be the test estab- 
lished by the Freedom of Information Act, 5 U.S.C. 552(b) (4). Our 
proposed amendment would have the effect of requiring nondisclosure 
of information obtained under the Toxic Substances Control Act 
which may be withheld under 5 U.S.C. 552(b)(4)., that is, "trade 
secrets and commercial or financial information obtained from a per- 
son and priviliged or confidential." This will make the confidentiality 
standard more definite (because there exists a body of case law inter- 
preting 5 U.S.C. 552(b) (4)), and will promote uniformity. 

In addition to the exemption for disclosure to Federal officers and 
employees, a separate provision should allow disclosure to EPA con- 
tractors and their employees, under appropriate safeguards and after 
appropriate EPA findings that disclosure is necessary. EPA accom- 



193 



77 

plishes a great deal of its investigatory and analytical tasks by con- 
tract. If contractors are not allowed access to information under this 
bill, EPA could not perform its duties satisfactorily without substan- 
tial manpower increases. The recently enacted Privacy Act, 5 U.S.C. 
552a, provides that, for purposes of the section of the Privacy Act 
which imposes penalties on Government employees for wrongful use 
or disclosure of information entitled to confidentiality, Government 
contractors and their employees are to be considered Government em- 
ployees (5 U.S.C. 552a (m) ). We recommend inclusion of such a pro- 
vision in the toxic substances bill. Our proposed amendments allow 
disclosure to contractors, and include a penalty for wrongful disclos- 
ure of information by Government employees (including contractors 
and their employees) . 

We also believe that the provisions relating to qualified scientists 
and individual names are not necessary. The term "qualified scien- 
tists" would be difficult to interpret, and in any event a scientist 
would have no greater rights under the subsection than would any 
person under our (proposed) basic confidentiality criterion. We be- 
lieve that the Federal Privacy Act and the Freedom of Information 
Act provide ample protection of the rights of individuals whose names 
appear in health and safety records. 

Finally, with regard to access of information by Congress, we be- 
lieve that such confidential information should be made available upon 
written request. 

Exemption from Federal preemption 

We do not rec(Hnmend the provisions of S. 776 which would allow 
State and local agencies to petition the Administrator for exemption 
from the Federal preemption requirements. State and local agencies 
would be allowed to regulate any toxic substance until such time as 
the Administrator puts into effect regulations for testing or restricting 
a substance. Thereafter, they could impose only a total ban on a sub- 
stance. In view of the fact that the bill authorizes the Administrator 
to regulate with respect to geographic areas there would appear to be 
no need for a State or local agency to duplicate any regulations with 
respect to a substance after Federal regulations are in effect. 

Interagency cooperation and coordination 

Several amendments are being proposed to the act to provide for 
the maximum cooperation and coordination among the several agen- 
cies of the Federal Government which have programs and responsibil- 
ities concerned with toxic substances. These amendments also would 
clarify that the act is intended to complement and supplement exist- 
ing laws and regulations such as the occupational health and safety 
requirements. 

A number of Federal agencies, particularly the Department of 
Health, Education, and Welfare and the Occupational Health and 
Safety Administration of the Department of Labor have extensive 
responsibilities relating to toxic substances and human health and 
would stand to benefit from various provisions of the act. For exam- 
ple, test results and other data generated in this area would, of course, 
be valuable to them and should be made available to all agencies 
concerned. 



194 



78 

We are also recommending that the provision contained in previous 
bills before the Congress directing the Council on Environmental 
Quality to coordinate a study on the feasibility of establishing a stand- 
ard classification system for chemical compounds and means of ob- 
taining rapid access to information on such substances be restored to 
the act. This section provides CEQ the lead in establishing information 
systems in a manner currently being initiated. This is being done in 
conjunction with the agencies that would have been represented on the 
interagencv committee as set out in the provision proposed to be de- 
leted. 

Appropriations 

We wish to make clear that our budget requests over the past several 
years have included funds to handle work anticipated to be required 
under toxic substances legislation, in the expectation that it would by 
now have been a reality. Consequently, considerable groundwork has 
been laid and we anticipate that activities during fiscal year 1976 can 
be met within the $8 million requested in the President's budget. Fur- 
thermore, we would point out that EPA wishes to remain in accord 
with the President's stated policy of holding new spending to an ab- 
solute minimum. Consequently we would point out that the authori- 
zation levels in S. 776 are in excess of amounts required to implement 
its provisions. 

We have outlined above in our letter a number of the proposed 
amendments to the act which we consider important : the attachment 
contains both these and additional amendments which we believe are 
of equal importance. We stronglv believe that the adoption of these 
amendments would improve and strengthen the legislation and en- 
able EPA to protect the health and the environment to the greatest 
practical extent while at the same time relieving the industry as well 
as the Government of some burdensome requirements. 

With the favorable consideration of these proposed amendments, 
we would urge the enactment of S. 776. 

My staff and I stand ready to assist your committee in any way 
possible. 

We are advised by the Office of Management and Budget that there 
is no objection to the submission of this report from the standpoint of 
the program of the President. 
Sincerely yours, 

John R. Quarles, Jr., 

Acting Administrator. 

Toxic Substances Control Act 

PROPOSED AMENDMENTS BY EPA AND OTHER FEDERAL AGENCIES TO S. 77« 

1. Definitions 

a. Page 4, lines 1 and 2, delete the language "or in some other way 
suitable for formation of a group for the purposes of this Act". 

Explamxition. — This amendment would delete the open-ended au- 
thority to designate almost any grouping as a "category of chemical 
substances". 



195 



79 

b. Page 4, line 5, delete paragraph (3) and insert new paragraph 

(3) "Chemical substance' means any chemical substance 
which (A) has an organic or inorganic particular molecular 
identity: (B) is any combined or uncombined radical or ele- 
ment; or (C) is any mixture; Provided^ however, the Ad- 
ministrator may by regulation exclude from this definition 
as it applies to tliis Act, or to any provision of this Act, cer- 
tain categories of chemical substances such as scientific labora- 
tory reagents and samples, or chemical substances not manu- 
factured in commercial quantities. 

Explanation. — This amended definition of a "chemical substance" 
would provide the Administrator with flexibility to exclude, in appro- 
piiate cases, substances from the requirements of the Act, or a par- 
ticular provision, where it does not need to be regulated, cannot be 
effectively regidated, or where meeting the requirements might be an 
undue burden. Scientific laboratory reagents, samples, and other chem- 
ical substances manufactured in less than commercial quantities are 
examples. 

We urge the following language be included in the committee report 
with respect to this definition : 

Chemical substance v.ould be defined to permit the Ad- 
ministrator the flexibility to provide by regulation for ex- 
empting chemical substances in certain categories or in less 
than connnercial quantities from certain provisions of the 
bill. With respect to those chemical substances, it is antici- 
pated that the Administrator will exercise his discretion to 
exclude, and thereby exempt, most of them from the testing 
provisions of the bill. The Administrator retains the author- 
ity to require testing in those cases where he finds a potential 
threat to health and the environment which indicates that 
such testing is necessary. 

c. Page 5, line- 2, delete the period and insert a semicolon after 
^'studies'' and delete remainder of paragraph ; and on line 12, delete 
"study-' and insert "study, including health and safety data developed 
pursuant to such study,". 

ExplanatloTi. — Correspondence relating to alleged adverse effects 
on health and similar reports are already required to be maintained 
in the section 8(d) regarding records, and an amendment is proposed 
to authorize the Administrator to require submission of such records. 
There is no need to include unconfirmed complaints and notices in 
the definition of health and safety data and confusion results when 
this is attempted. It is also proposed to specifically provide that a 
health and safety "study" includes health and safety data develdped 
pursuant to such study,". 

d. Page 6, insert after line 14 the following and renumber other 
paragraphs accordingly. 

(15) "new chemical substance" means any chemical sub- 
stance which has not been manufactured or imported in com- 
mercial quantities into the United States during the 18-month 



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80 

period immediately prior to the effective date of this Act, 
regardless of its commercial production or importation in the 
United States prior to such time. 

Explanation. — -A definition of "new chemical substance" is neces- 
sary in order that chemical substances that were used in prior years 
and were discontinued do not become classified as existing cheniicals 
for purposes of this Act. 

2. Testing 

a. Page 9, after line 8, insert new paragraph (4) as follows: 

(4) The Administrator will consider alternative methods 
for meeting the standards for test protocols proposed by any 
person or governmental entity which is a manufacturer, proc- 
essor, or importer of such chemical substance. 

Explanation— This amendment would specifically direct the Ad- 
ministrator to consider alternative methods for meeting the standards 
for test protocols proposed by a manufacturer, such as less costly or 
more effective test protocols. 

b. Page 9, line 14, delete the last two sentences in paragraph (1) 
beginning with "If", and insert in lieu thereof : "If such an arrange- 
ment is made the Administrator shall be notified and the remaining 
such persons shall be exempted from requirements to perform tests." 

Explanation. — ^We do not believe that the Administrator should 
become involved in designating which part}^ (or a third party) should 
perform tests if the parties cannot agree among themselves. If a cost- 
sharing arrangement is made for one of the parties to do the testing, 
however, provision should be made to exempt the other parties from 
the testing requirements. 

c. Page 11, line 15, insert after "arguments," the following: "and 
permit cross-examination to such extent and in such manner as in his 
discretion he determines is necessary and appropriate in view of the 
nature of the issue involved, the number of the participants and the 
nature of the interests of such participants,". 

Explanation. — This amendment would permit limited cross-exam- 
ination as is provided in the section 6 rulemaking procedures to restrict 
toxic chemicals. 

3. Premarket screening; imminent hazard 

a. Page 12, line 3, after "substance" add the following sentence: 

Subsequent submission or request for submission of addi- 
tional information shall not be regarded as changing the date \ 
of such notice. 

Page 13, line 4, delete entire subsection (c) ; on line 25, delete be- 
ginning with "Unless" through "90 days" on line 2, page 14, and 
insert in lieu thereof "Ninety days" ; renumber following subsections 
accordingly. 

Page 14, line 10, after "substance" insert "before or". 

Page 22, line 13, after "environment," insert "that should be cor- 
rected immediately, and". 

Explanation. — ^These amendments will delete the authority in the 
bill to treat a rule proposed under section 6 during the premarket re- 
view period of a product as a final rule. 



197 



81 

Thus a chemical substance or procluct may be manufactured and 
distributed after the premarket review period unless a restriction is 
obtained under the imminent hazard provision of the Act The sub- 
stance or product, however, remains subject to all other provisions of 
the Act and a rule proposing restrictions on the substance or product 
may be proposed immediately durin^: the premarket review period 
under section 6 and the rule-making proceedings initiated at that 
time. 

If it appeal's that the manufacture, processing, or distribution of a 
chemical substance or product will result in any unreasonable threat 
to human health or the environment prior to tJie completion of the 
rule-making proceedings, action may be taken to restrict or ban it 
under the imminent hazard provisions of the bill, thus preventing it 
from becoming a threat to health or the environment. 

The other amendments would clarify the date premarket notice 
commences, that restrictive rules under section 6 may be- promulgated 
before or after manufacture or distribution of a substance, and that 
an imminent hazard is a risk that should be corrected immediately. 

4. Restnctions on hazardous chemical substances 

a. Page 17, line 23, delete "condition" and insert in lieu thereof 
"circumstances'*, and insert the following language in the committee 
report with respect to section 6 of the bill : 

The provisions of section 6 of S. 776 provide EPA with 
regulatoiy authority which will complement and supplement 
existing authority to control hazardous substances but not to 
preempt authority already vested by statute in other Federal 
departments or agencies. Proposed new section 9(b) would 
preclude EPA from taking action under sections 6 and 7 
which the Secretary of Labor could take imder the Occupa- 
tional Safety and Health Act. Thus, for example, the Ad- 
ministrator of EPA could not. under section 6(a) (3) require 
that a substance be lal>eled so as to prescribe requirements for 
its safe and healthful use which apply solely, to workers in 
their place of employment. The Department of Labor, pur- 
suant to the Occupational Safety and Health Act of 1970, 
already has autliority to prescribe safe and healthful work- 
ing conditions. Similarly, section 6(b)(2) shall not be con- 
strued to allow tlie Administrator of EPA to establish occupa- 
tional safety and health standards. 

Explanation. — The clarification to paragraph 6(a)(2), together 
with the addition of le^rislative history with respect to paragraphs 
6(a) (3) and 6(b) (2), will assist in implementation of the bill's policy 
to "complement and supplement" existin^r authority. These changes 
will assist in avoidini? overlap between EPA and the Department of 
Lalx)r*s workplace safety and health authority. 

b. Page 18, line 17, paofe 20, line 23, paoe'21, lines 6 and 12, delete 
"adulterated" (or "adulteration") and insert in lieu thereof "con- 
taminated" (or "contamination"). 

Explanation. — We believe that the term "contaminated" (or "con- 
tamination") would more clearly express the intent of these provisions 
instead of "adulterated" which is often undei-stood or defined as an 
intentional act. 



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82 

c. Page 19, line 11 , delete entire para^ra ph ( 3 ) . 

Explanation. — ^We believe that the Administrator should not be- 
come involved in assigning quotas to industry. The mandatory re- 
quirement of a quota system would make the regulatory process vastly 
more cumbersome and difficult to administer. The Act already pro- 
vides that when it is necessary to adoj^t a rule with respect to a chemi- 
cal substance to protect against an unreasonable risk, the Administra- 
tor shall select the least stringent requirement practicable consistent 
with protection of the health and the environment. It is expected that 
the establishment of quotas would seldom, if ever, be necessary as such 
would be a most stringent requirement. Xevertlieless, we strongly rec- 
ommend against becoming involved in the establishment of quotas.. 

d. Page 20, after line 15, insert the following : 

(4) the economic impact of sucli action, including, but not 
limited to, consideration of the effects on business, employ- 
ment, and the national economy. 

Expla/nation. This amendment would specifically require the Ad- 
ministrator to consider economic impact in promulgating regulations,. 
alreach'" inherent in the requirement that he consider all relevant fac- 
tors. This would be in lieu of proposals that have been made for th& 
mandatory preparation of detailed economic impact statements for 
issuance at the time any regulation is promulgated. 

5. Suits hy U.S. attorneys instead of hy Administrator' 

Page 22, line 17, delete all after "may" thi ough "so,", line 19 and in- 
sert in lieu thereof : "request a United States Attorney to petition an 
appropriate district couit of the United States'' 
Page 39, line 3, delete "Administrator or the". 

Page 46, line 7, delete "Administrator (or Attorney General on his 
behalf) " and insert in lieu thereof "Attorney General". 

Page 46, line 8, after "commenced" delete "and is diligently prose- 
cuting" on lines 8 and 9. 

Explanation. — These amendments would carrv out the long-time 
policy of having the Justice Depaitment l esponsible fpr litigation in- 
stead of. each Agency. In the citizen suit provisions, wc believe that it 
is sufficient if the Attomev General has commenced an action and that 
it is not necessary to impose a further requirement that he be diligent- 
ly prosecuting it, a concept which is at best difficult to litigate and at 
worst could lead to counter-productive court action. 

(S. Sid)mi8siono_f records; health and safety studies 

a. Page 25, line 3, add at end of sentence : 

The* Administrator may require copies of such records pur- 
suant to his responsibilities under sections 4, 5, 6, and 7 of this 
Act. 

Explanation. — Wiile the bill provides that records of adverse health 
effects caused by chemical substances are required to be maintained, 
no provision is made to require submission of such records. This 
amendment would correct that omission. 

b. Page 25, line 4, delete subsection (e) and insert in lieu thereof: 

;(e) Health and Safety Studies. The Administrator shall 
promulgate regiilations under which he may require any per- 



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8:i 

son who manufactures, processes, or distributes in commerce 
any chemical substance (or with respect to paragraph (3), 
any person who has possession of a study) to submit to him— 

(1) lists of health and safety studies in progress on or 
initiated after the date of enactment of this Act, con- 
ducted by or for such person, or known to such person; 

(2) lists of health and safet}^ studies conducted by or 
for such person, or known to have been made by any per- 
son, prior to the date of enactment of this Act ; 

(3) copies of any such studies appearing on a list sub- 
mitted pui^suant to paragraphs (1) or (2), or otherwise 
known by him. 

Explanation, — Tliis amendment would revise the provision re- 
quiring industry to report on or submit all health and safety studies. 
It would requii e submission of lists of ongoing and new studies rather 
than the study, with a right to require submission of studies. It would 
authorize the Administrator to provide by regulation for the types of 
studies to be included on the lists, and the number of years of prior 
studies for particular types of studies; and would require a person to 
also list studies which he knows are being made or have been made. 

7. Additional exemptwn : additional limitation on authority 

. a. Page 26, line 8, delete "or"; line 10, after '*Act)" insert a comma 
and add "cosmetics (as such term is defined in section 201 (i) of the 
Federal Food, Drug, and Cosmetic Act),''; line 18, replace the period 
with a semicolon, and add the following : 

(3) any source material, special nuclear material or by- 
product material as defined in the Atomic Energy Act of 
1954 (42 U.S.C. 2011), as amended, and regulations issued 
pursuant thereto ; or 

(4) tobacco and tobacco products. 

Explanation, — We believe that cosmetics should also be exempted 
and materials regulated under the AEC Act, and do not believe that 
tobacco products.should be regidated under the Toxic Substances Con- 
trol Act. 

b. Page 26, after line 18, add new subsection (b) as follows, and 
renumber other subsections accordingly : 

(b) Notw^itlistanding any provision of this Act, the 
Administrator shall have no authority under sections 6 and 7 
of this Act to take any action which^the Secretary of Labor 
is authorized to take pursuant to the Occupational Safety and 

Health Act. In exercising authority pursuant to this Act, the 
Administrator shall not, for the purposes of applying sec- 
tion 4(b) (1) of the Occupational Safety and Health Act, be 
deemed to be exercising statutory authority to prescribe or 
enforce standards or regulations affecting occupational safety 
and health. 

Explanation. — The purpose of these changes is to eliminate the pos- 
sibility of jurisdictional conflicts between EPA and the Department of 
Labor where actions taken by one authority might otherwise preclude 
or duplicate action of the other. 



200 



84 

8. Interagency cooperation and coordination 

Page 3, after line 17^ add the following new paragrapli : 

(5) such authority over chemicals be exercised in such a 
manner as to complement and supplement existing Federal 
policies, regulations, and public laws regarding the protection 
of health and the environment, including occupational health, 
consumer safety, food, drug, and cosmetic authorities. 

Page 28, line 3, delete the sentence after "coordination. — " and insert 
in lieu thereof : 

In administering the provisions of this Act, the Adminis- 
trator shall consult and coordinate with the relevant agencies 
and instrumentalities of the Federal Government in accord- 
ance with the policies set forth in section 2(b) of this Act. 

Page 30, line 2, delete the last sentence of subsection (a) and insert 
in lieu thereof : 

The Administrator is authorized to make contracts and 
grants for research and monitoring as necessary to carry out 
the purposes of this Act in consultation with the Secretary of 
Health, Education, and Welfare on such contract and grant 
programs. 

Page 30, line 7, delete entire subsection (b) and insert new subsection 
(b) as follows: 

(b) The Council on Environmental Quality in consultation 
with the Administrator, the Secretary of Health, Education, 
and Welfare, the Secretary of Commerce, and the heads of 
other appropriate departments or agencies, shall coordinate a 
study of the feasibility of establishing ( 1 ) a standard classifi- 
cation system for chemical compounds and related substances, 
and (2) a standard means for storing and for obtaining rapid 
access to information respecting such materials. A report on 
such study shall be published within 18 months after enact- 
ment of this Act. 

Expl/jfn/ition. — ^These proposed amendments are intended to clearly 
set forth that it is the policy of the Act that there be the maximimi co- 
operation and coordination among the several agencies of the Federal 
Government which have programs and responsibilities concerned with 
toxic substances ; that the Act is intended to complement and supple- 
ment existing laws and regulations such as the Federal occupational 
health and safety requirements; and that appropriate provisions are 
made to establish and to have access to information relating to chemi- 
cal compounds. 

A number of Federal agencies, particularly the Occupational 
Health and Safety Administration of the Department of Labor have 
extensive responsibilities relating to toxic substances and human health 
and would stand to benefit from various provisions of thie Act. The 
testing of chemicals as they relate to the programs of these agencies 
and the test results and other information and data generated by the 
legislation would, of coui*se, be valuable to them and must be made 
available. 



201 



• 85 

One of these amendments specifically provides that the EPA Ad- 
ministrator will consult with the Secretary of Health, Education, and 
Welfare on any contract and ofrant programs for carrying out the 
research and monitoring activities under the Act, but not necessarily 
on each individual contract or grant. 

We are also recommending that the provision contained in the 
previous bills before the Congress directing the Council on Environ- 
mental Quality to coordinate a study on the feasibility of establishing 
a standard classification system for chemical compounds and means 
of obtaining rai)id access to tlie information on such substances be 
restored to the Act. This section provides CEQ to have the lead in 
establisliing information systems in a manner currently being initiated. 
This is being done in conjunction witli the agencies that would have 
been represented on the interagency committee as set out in tlie pro- 
vision proposed to be deleted. 

0. AddiftOTinl ass/'.'^frrnf ac^Tninhfrafor 

Page 28, line 15, delete subsection (a), renumber subsections (b) 
and (c) accordingly. 

ExplanaMov. — This amendinont would deleie the provision for a 
special category Assistant Administrator for Toxic Substances. 

10. Administrative inspections 

Page 31, line 6, insert "(a)" after "Sec. 12", and after line 21 insert 
new subsection (b) : 

(b) Notwithstanding the provisions of subsection (a), the 
Administrator shall have authority to inspect financial data 
records pertaining to testing costs when he orders contribu- 
tion or reimbui^sement for the costs of performing tests in 
connection with the provisions of sections 4(c) and 5(f). 
Explanation. — Section 4(c) and 5(f) authorize the Administrator 
to determine the equitable contribution or reimbursement of testing 
costs where more than one person benefits from the testing. This 
amendment would authorize access to financial data on testing costs 
in order for the Administrator to carry out the requirement to appor- 
tion the costs among those benefits from the testing. 

11. Disclosure of can-fidential information 

Page 34^. line 18, delete entire section 15 and insert in lieu thereof 
the following revised section : 

CONFmENTlALITT 

Sec. 15. (a) Centrai^ — Any information reported to, or 
otherwise obtained by, the Administrator or his representa- 
tive under this Act/ which is exempt from mandatory dis- 
closure by reason of section 552(b) C4) of title 5, United 
States Code, shall be entitled to confidential treatment and 
shall not be disclosed by the Administrator or by any officer 
or employee of the United States, except that such informa- 
tion may be disclosed. 

(1) to officers and employees of the United States in 
connection with their official duties : 

(2) to contractors with the United States and em- 
ployees of such contractors, if in the opinion of th? Ad- 



202 



86 

mmistrator such disclosure is necessary for the satisfac- 
tory performance by the contractor of a contract with 
the United States entered into on or after the effective 
date of this Act for the performance of work in con- 
nection with this Act ; 

(3) when relevant in any proceeding under this Act, 
except that disclosure in such a proceeding shall be made 
in such manner as to preserve confidentiality to the ex- 
tent practicable without impairing the proceeding; or 

(4) to the extent that the Administrator determines 
it is necessary to protect health or the environment. 

(b) Access by ConcxRess. — Notwithstanding any limitation 
contained in subsection (a) or any other provision of law, 
all information reported to or otherwise obtained by the 
Administrator or his representative under this Act shall be 
made available upon written request of any duly authorized 
committee of the Congress. 

(c) Criminal Penaett for Wrongful Disceosure. — (1) 
Any officer or employee of the United States, or former officer 
or employee of the United States, who by virtue of his em- 
ployment or official position has obtained possession of, or 
has access to, material which is entitled to confidential treat- 
ment under subsection ( a), and who laiowing that disclosure 
of the specific material is prohibited by this section, willfully 
discloses the material in any manner to any person not en- 
titled to receive it, shall be guilty of a misdemeanor and 
fined not more than $5,000. 

(2) For the purposes of this subsection fc), any contrac- 
tor with the United States who is furnished information pur- 
suant to subsection (a) (2), and any employee of any such 
contractor, shall be considered to be an employee of the United 
States. 

Exflmwitim. — This section should be amended in several respects 
First, the substance criterion for withholding data as confidential 
should be the test established by the Freedom of Information Act, 5 
U.S.C. 552(b)(4). Our proposed amendment would have the effect 
of requiring nondisclosure of information obtained under the Toxic 
Substance Control Act which may be withheld under 5 U.S.C. 552 
(b)(4), i.e., "trade secrets and commercial or financial information 
obtained from a person and priveleged or confidential." This will make 
the confidentiality standard more definite (because there exists a body 
of case law interpreting 5 U.S.C. 552(b)(4)), and will promote 
uniformity. 

In addition to the exemption for disclosure to Federal officers and 
employees, a separate provision should allow disclosure to EPA con- 
tractors and their employees, under appropriate safeguards and after 
appropriate EPA findings that disclosure is necessary. EPA accom- 
plishes a great deal of its investigatory atid analytical tasks by con- 
tract. If contractors are not allow^ed access to information under this 
bill, EPA could not perform its duties satisfactorily without substan- 
tial manpower increases. The recently-enacted Privacy Act, 5 U.S.C. 
552a, provides that, for purposes of the section of the Privacy Act 



203 



87 

which imposes penalties on Government employees for wrongf'ul use 
or disclosure of information entitled to confidentiality, Go\nernment 
contractors and their employees are to be considered Governnlent em- 
ployees (5 U.S.C. 55'2a(m). AVe recommend inclusion of such a pro- 
vision in the toxic substances proposed bill. Our amendments allow 
disclosure to contractors, and include a penalty for wrongful disclosure 
of information by Government employees (including contractors and 
tlieir employees). 

We also believe that the provisions relating to qualified scientists 
and individual names are not necessary. The term ''qualified scientists'' 
vrould be difficult to interpret, and in any event a scientist would have 
no greater rights under the subsection than would any person under 
our (proposed) basic confidentiality criterion. We believe- that the 
Federal Privacy Act and the Freedom of Information Act provide 
ample protection of the rights of individuals whose names appear in 
health and safety records. 

Finally, with regard to access of information by Congress, we 
believe that release of such confidential information should be upon 
written request. 

12. ^tate exemption from Federal preemption 
Page 42, line 14, delete subsection (b). 

Fxplanati-on. — This amendment would delete the pronsion that 
w^ould allow State and local governments to petition to be exempted 
from Federal preemption requirements. 

13. Citizen suits for discretionary action 

Page 45, line 13, delete language after ''Act" through line 16, and 
insert in lieu thereof: "which is not discretionary with the Adminis- 
trator.". 

Explanation. — This amendment would make the provision conform 
with the usual citizen suit provision and not authorize suits against 
the Administrator for discretionary acts. It would thus prevent the 
possibility of .every decision of the Administrator from being re- 
decided in the district courts. 

14. I ndemmfication study 

Page 52, line 17, delete all of section 25 and renumber section 26 
accordingly. 

Explanation. — This amendment would delete the requirement for 
a study on Federal indemnification under laws administered by EPA. 
We believe sufficient information already exists to recommend against 
indemnification under programs administered by EPA. 

15. Suhndss^ioyis of budgets and, testimony to Congress 
Page 54, line 15, delete all of subsection (c) . 

Explanation^ — This amendment would delete the requirenient that 
Agency budget requests, testimony and comments on legislation must 
not be submitted to OMB prior to submission to Congress. We continue 
to object to this provision. 

16. Addituyj-iul miscellaneous amendments 

Page 2, line 16, add after "substances": "which may present an un- 
reasonable risk to health or the environment." 



204 



88 

Page 3, line 8, insert after "to" the following : "ensure that adequate 
testing is conducted by those persons who manufactui-e, import or 
process, to ". 

Page 5, line 17, after "ecological studies" insert "monitoring 
studies,". 

Page 8, line 4, delete "proscribed" and insert "prescribed". 
Page 8, line 20, insert after "that" "one or more of the following". 
Page 8, line 24, insert after "synergistic properties," "persistence,". 
Page 10, line 6, delete "section 5 (g) " and insert "section 5(f) ". 
Page 22, line 12, delete "any". 

Page 22, line 13, delete "threat" and insert in lieu thereof "risk". 

Page 29, line 1 5, delete the period and add "if appropriate.". 

Page 33, line 20, delete "delivery" and insert in lieu thereof "re- 
lease"; line 22, delete "three months" and insert in lieu thereof "90 
days"; and on line 25, delete "deliver" and insert in lieu thereof 
"release". 

Page 34, line 1, after "decision" insert "by the Administrator"; line 
4. delete "article, together with the" and insert in lieu thereof "article 
as set forth in the Customs entry plus the estimated"; line 5, delete 
"forfeiture of" and insert in lieu thereof "liability for assessment of 
liquidated damages equal to"; line 6 delete "refusal" and insert in lieu 
thereof "failure"; line 10, delete "delivery" and insert in lieu thereof 
"release" ; line 11, insert a comman after "payment" and delete "of and 
the comma after "charges"; and on line 16. delete "of subsection (a)". 

Page 39, line 5, "section 17," should read "section 16,". 

Explanation. — These amendments are technical corrections or are 
otherwise self-explanatory. 



205 



ADDITIONAL VIEWS OF MR. BAKER 

In my view, the Toxic Substances Control Act which is die subject 
of this Committee Report represents a considerable improvement over 
past efforts to develop le<rislation in this field, and I support the bill. 
There is clearly a need for re^rulatory^ authority which can, where pos- 
sible, identify and control the introduction of harmful substances into 
the environment before damajre to health or the environment occurs. 
This bill permits regulation of toxic chemicals at points in the chain 
of manufacture and use that are impossible to reach under exist in^:: 
laws. In addition, the concept of premarket screening Tvill, in some 
cases, prove a boon to industry by providing a mechanism whereby a 
hannful substance can be halted before a manufacturer has invested a 
g]-eat deal of time and money in marketing and distributine: it. 

'WHiile I opposed some of the amendments which were added to the 
measure during the Committee's mark-up. I will confine these views 
to a discussion of one section of the bill which was the sui)ject of an 
amendment I offered. Unfortunately, that amendment was rejected by 
iho Committee. 

Section 4(e)(1) of the bill as reported creates an interagency advi- 
sors^ committ^^e to advise the Administrator as to those chemicals 
which should be priorities for testing. The priority list is required to 
be published in the Federal Register, and the Administrator is required 
to institute a rulemaking procedure to develop testing requirements on 
these chemicals within 1 year or publish his reasons for not doing so. 

These reouirements pose several problems for both the industry and 
the Administrator which I believe the Committee has negle^tod to 
address adequately. First, publication of a priority list in the Federal 
Register is likely to generate a good deal of publicity in the media 
which will inevitably result in a perception by the public that chemi- 
cals on the list are harmful, even though they will not, at this point, 
have undergone testing for toxicity. This "blacklisting" effect will, in 
my opinion, work a substantial unfairness on manufacturers of prod- 
ucts which contain a chemical appearing on the list. 

While T feel strongly that the public should be advised of hannful 
chemicals in the marketplace, I see little or no benefit in mandatory 
disclosure of the advisory committee's list prior to any decision by the 
Administrator that those chemicals do, in fact, meet the criteria for 
testing established by the bill. Other sections of the bill provide for 
disclosure to the public of test data received by the Administrator, as 
well as information received when a chemical undergoes premarket 
screening. Moreover, section 14 of the bill requires the Administrator 
to disclose any information he has if he determines it is necessary to 
protect human health or the environment. These provisions insure 
continuing dissemination to the public through the Federal Register of 
information pertaining to the administration of the Act. 

(89) 



206 



90 

Secondly, I do not believe that requiring the Administrator to take 
action on the advisory committee's list within 12 months or publish 
his reasons for not taking action is consistent with the proper role of 
an advisory committee. This requirement effectively removes the deci- 
sion on whether to require testing from the Administrator and places 
it in the hands of the advisory committee — an entity not responsil:)le 
for administration of the Act. The priority list developed by the com- 
mittee should be received and evaluated by the Administrator as a 
recorrimetidation. By requiring that he act on the advisory committee's 
recommendation, the bill removes from the Administrator the flexi- 
bility which he will need to make responsible decisions on the testing 
of chemicals. 

Howard H. Bakeh, Jr. 



SENATE COXSIDERATIOX OF S. 3149 



[Excerpt from the Congressional Record, Mar. 26, 1976, Senate, pp. S4397-S4432] 

Toxic Substances Control Act 

The Senate continued with the consideration of the bill (S. 3149) 
to regulate commerce and protect human health and the environment 
by requiring testing and necessary use restrictions on certain chemi- 
cal substances, and for other purposes. 

Mr. TuNNEY. Mr. President, today the Senate will be considering 
S. 3149, the Toxic Substances Control Act. In my view this legislation 
is the most important environmental and health protection legislation 
that will come before the Congress this session. S. 3149 will close major 
gaps in the law that leave the public inadequately protected against 
the unregulated introduction of hazardous chemicals into the environ- 
ment. S. 3149 will assure that chemicals will receive careful premarket 
scrutiny before they are manufactured or distributed to the public. 
This provision will end the present situation where chemicals can be 
marketed without notification of any governmental body and without 
any requirement that they be tested for safety. Thus, this legislation 
will no longer allow the public or the environment to be used as guinea 
pigs in order to determine the safety of these chemicals and products. 

Mr. President, S. 3149 was reported unanimously from the Senate 
Commerce Committee. Furthermore, support for a strong toxic sub- 
stances bill is extremely widespread. Dr. Russell Peterson, Chairman 
of the Council on Environmental Quality for example, concluded at 
last year's hearings: 

Toxic substances legislation is probably the most important environmental 
legislation now before the Congress, 

This view was echoed in a February 28, 1976, Washington Post edi- 
torial which stated in part : 

In light of all that has been learned about environmental threats to health, 
it hardly seems unreasonable for Congress to require that substances should not 
be marketed until their health effects have been assessed as well as possible, and 
no serious hazards have been found. That course will not produce a world en- 
tirely free of risk. But it will inject far more care into the realms of chemistry 
and slow down the rate at which strange substances are spread about. Given the 
persistent and insidious nature of many toxic materials, precaution is not just 
important but imperative. 

The need for this legislation has become increasingly clear. In the 
last 3 years, for example, I have chaired hearings before the Senate 
Committee on Commerce which have documented time and again the 
lethal dangers associated with chemicals like vinyl chloride, bischloro- 
methyl ether— BCME— mercury and other heavy metals, arsenic, as- 
bestos, and a multitude of others. In fact, over the 15 days of hearings 

(207) 



208 



conducted by the Committee on Com'hierce on this legislation over the 
last 5 years, in excess of 100 chemicals have been mentioned as candi- 
dates for regulation under this legislation. 

Also, the National Cancer Institute has estimated that 60 to 90 per- 
cent of the cancers occurring in this country are a result of environ- 
mental contaminants. Many doctors and scientists now believe that 
cancer, which has been projected to kill as many Americans in 1975 as 
all the battle deaths in Vietnam, Korea, and the Second World War 
combined, appears particularly susceptible to a preventative approach 
through control of toxic substances. 

It is indeed unfortunate that while the record of chemical dangers 
continues to grow, segments of the chemical industry have presented 
roadblocks at every juncture of this bill's development. There is no 
question in my mind that a statute would now be on the books provid- 
ing effective protection against chemical hazards had it not been for 
the concerted effort of certain segments of the chemical industry to gut 
the essential provisions of this legislation. 

Russell Train, Administrator of the Environmental Protection 
Agency, for example, discussing this lobbying effort has noted : 

It is unfortunate that some segments of the chemical industry, which origi- 
nally took an extremely constructive approach toward the legislation, has taken 
to actively lobbying against it, I do not believe that either the public interest, or 
the interests of the industry, are well served by charges that the legislation 
could — in words of one industry spokesman — "cripple" the chemical industry and 
give the Administrator of EPA "near-dictatorial authority over the introduction 
of new chemical products." The only real "crippling" that is going on is the kind 
which this legislation would try to prevent — the crippling of who knows how 
many Americans every year who contract cancer or some other affliction after 
exposure to some hazardous chemical agent. Nor has it been on the "near-dicta- 
torial authority" of the EPA Administrator that so many such agents are intro- 
duced into the environment without any effort to find out what their health effects 
are, much less the public have any say about whether or not, or in what circum- 
stances, it is willing to be exposed to them. Let there be no mistake; the only 
kind of authority that the legislation before the Congress would give us, the only 
kind of authority we would intend to exercise, is the authority to act reasonably 
and responsibly in the public interest — and that includes the very real interest 
the public has in a healthy and productive chemical industry. 

In order to provide EPA adequate regulatory authority, the Toxic 
Substances Control Act will provide a mechanism to insure that that 
information with respect to health and environmental effects of chemi- 
cals can be collected from manufacturers and processors of chemical 
substances prior to manufacture. The bill contains the following im- 
portant provisions : 

Eirst, manufacturers of new chemical substances must irive notifica- 
tion to EPA 90 davs in advance of first manufacture and. if required 
by EPA, include test data along with such notification [Sec. 5]. 

Second, the EPA Administrator may require manufacturers to test 
or have tested those chemical substances which he determines may 
present an unreasonable risk of iiijury to health or the environment 
or those for which significant human or environmental exposure takes 
place or will take place. This provision is applicable both to new and 
existing chemical substances [Sec, 4], 

Third, manufacturers or processors of chemical substances are re- 
quired to retain certain records and reports that will better enable the 
Administrator to determine if unreasonable risks exist. Also manufac- 



209 



turers must provide the Administrator with a list of health and safety 
studies on various chemical substances. The Administrator is author- 
ized to require the submission of any study on the list. This provision 
is included due to the fact that, in hearings of the Committee on Com- 
merce that I chaired, it was strongly alleged that health information 
that suggested certain chemicals were dangerous had been suppressed 
by industry from both the (jovernment and chemical workers [Sec. 8]. 

Fourth, citizens are authorized to bring suit to enjoin violation of 
this act and to require the Administrator of EPA to perform his 
mandatory duties [Sec. 20]. 

Fifth, citizens are authorized to petition the Administrator to take 
action the purpose of which is to protect against unreasonable risks of 
injury to health or the environment. If the Administrator fails to take 
action within 90 days on such petition or denies it, judicial review of 
the denial or failure is authorized [Sec. 21]. 

Sixth, discrimination against any employee who participates in 
proceedings, testifies in a proceeding, or participates in any other 
action necessary to carry out the purposes of the legislation is pro- 
hibited. The legislation also sets up procedures to protect such 
employees [Sec. 23]. 

Certain industry representatives have claimed that this legislation 
will be detrimental to the economic health of the chemical industry. I 
believe this view is totally unjustified. The chemical industry in the 
last year had estimated sales of over $100 billion. The Environmental 
Protection Agency and General Accounting Office both have estimated 
that the costs of this legislation will be somewhere between $100 and 
$200 million a year. This cost is completely justified in light of the 
need for protection of the public from potentially vast damage to 
health and the environment. 

The chemical industry will reap very real benefits from this legis- 
lation as well. A prudent approach of premarket investigation and 
scrutiny will reduce the likelihood that we will have to take action 
against a chemical after industry has invested vast resources in its pro- 
duction and marketing, f'urthermore, as Russell Train has pointed 
out — 

Far from stiffling innovation toxic substances legislation should serve to en- 
courage the industry to turn its remarkable skills and resources towards the 
discovery and use of less hazardous chemicals. 

^Ir. President, I do not think there is a way to assure a risk free 
society. However, the Toxic Substances Control Act will end the situa- 
tion where we play Russian roulette by introducing vast numbers of 
untested chemicals into the environment. This legislation will assure 
that we will no longer thave to wait for a body count or serious health 
damage to generate controls over hazardous chemicals. Mr. President, 
in closing these remarks I would like to provide a partial list of the 
groups that have called for strong toxic substances legislation : 

AFL-CIO. 

Blue Cross Association. 

American Lung Association. 

Center for Science in the Public Interest. 

Consumer Action Now. 

Consumer Federation of America. 



210 



Environmental Action. 
Environmental Defense Fund. 
Environmental Lobby. 
Environmental Policy Center. 
Friends of the Earth. 

Industrial Union Department, AFL-CIO. 

Lea^iue of Women Voters. 

National Audubon Society. 

National Foundation— March of Dimes. 

Natural Eesources Defense Council. 

National Wildlife Federation. 

Oil, Chemical and Atomic Workers. 

Pulp and Paperworkers. 

Sierra Club. 

Textile Workers. 

United Auto Workers. 

United Mine AVorkers. 

United Steel Workers. 

Urban Environment Conference. 

When I became a member of the Committee on Commerce 3% years 
aofo. Senator Ma;^nuson asked me if I would be interested in chairing 
some hearings on the toxic substances bill, inasmuch as the bill had 
been before the committee for the preceding 2 years and there had not 
been any final action taken, as a result of the very strong lobbying in- 
fluence of the chemical industry. So, approximately 31/2 years ago, I 
started holding hearings on the legislation, with the idea of being 
able to move it quickly through Congress. We were able to get it 
through the Senate without any difficulty 3 years ago. Then we got to 
conference, and it was very clear in conference that the chemical indus- 
try had marshaled its forces and was going to do everything it could 
to sabotage the legislation in a way that was considered unacceptable 
not only to the Environmental Protection Agency, but to the Senate 
conferees as well. 

I must say that I have never seen such an effective lobbying effort 
as was done against this legislation. I was the chairman of the Senate 
conferees and, for a period of 18 months we sat in conference with no 
appreciable headway being made because some of the vital provisions 
of this legislation, such as permarket notification, were provisions that 
were unacceptable to the House conferees. We could not get the spokes- 
men against the legislation who were on the conference committee to 
agree to ameliorating the strong opposition that they had to those 
provisions in the legislation. 

But a lot has happened in the last 2 years. Particularly, a lot has 
happened in the way of educating the public in the last several months. 
We had a 60-minute CBS television special which outlined the impact 
of environmental cancer on society. We haA^e had the National Insti- 
tutes of Cancer come out with studies demonstrating that between 60 
and 90 percent of cancer is environmentally induced. We have, had a 
cover story in Newsweek demonstrating the impact of environmental 
cancers on our society. We have had, in the last year, a large increase 
in the rate of cancer afflicting society, some 3 percent last year over the 
year before. 



211 



I introduced into the Record yesterday an article which showed that 
cancer has now become the number one killer of youngsters 15 and 
under. There does not seem to be any question that it is the enyiron- 
mental carcinogens that are producing this cancer in youngsters. 

In other words, Mr. President, what I am saying is that I think that 
tliis legislation is yitally needed and. despite the fact that there may 
be significant costs to the industry, it is going to saye the public 
billions and billions of dollars in medical treatment to get rid of can- 
cer. And, of course, it is going to saye, in my yiew, thousands of liyes. 

The thing that we haye learned in recent years about cancer which 
is so deyastating for those of us who are concerned about our friends 
and our families is that you can be exposed to a carcinogen and neyer 
know that you haye been exposed to it. It is a silent death. It takes 
maybe 20 to 25 yeai^ to kill you, but that death is just as sure in some 
instances as haying put a reyolyer to your temple and pulled the 
trigger and haye a bullet go into your brain. 

I was horrified to learn that we haye asbestos in many of our body 
powders, and that Ayhen youngsters' mothers put powder on them, this 
can be inhaled into their lungs and that asbestos sits in the follicles 
of the lung and can produce cancer 20 years later. 

In the late forties or early fifties, we used to spray the ceilings of 
our schools with asbestos and now this asbestos is flaking off and can 
get into the atmosphere of the school, the classroom, and children can 
inhale it and, in 20 or 25 years, die of cancer. 

The same is true of yinyl chloride. Back in the late forties and early 
fifties, workers were exposed to yinyl chloride in a way that could 
produce cancer today. People working in the factories would go down 
and work in the reaction yats with the yinyl chloride all around them, 
inhaling it at a leyel of parts per million that, if they were all sus- 
ceptible to cancer, was sure to produce the cancer. Lord knows how 
many people are going to die of yinyl chloride-induced cancer. 

The point simply is we haye learned a tremendous amount about the 
causes of cancer in the last 25 years, not so much as we would like to 
learn about how to cure it, but an awful lot about the causes of cancer. 
It seems to me that this legislation, which is designed to giye the 
Enyironmental Protection Agency a degree of regulatory control oyer 
the introduction of new chemicals into the enyironment, is absolutely 
basic. I haye many friends who are in the chemical industry. But I 
cannot imagine persons arguing against this degree of regulatory con- 
trol oyer the industry. 

As I say, if you are going to cost it out on an economic basis, on the 
basis of cost/benefit, you are going to find it is going to saye billions 
of dollars to consumers in medical treatment that they will not need 
as a result of not being exposed to carcinogens in future years. 

I would like to say that I deeply appreciate the leadership that has 
been shown by the chairman of the full committee. Senator Magnuson, 
in ])ushing tliis legislation for the past 5 years. If it had not been for 
his interest and his keeping the pressure on I do not know, but I am 
sure we would not haye the hiW before us today. 

Mt, ^NIagnusox. ^It. President, I rise to strongly urge the passage 
of the Toxic Substances Control Act. The Senate Commerce Com- 
mittee has worked diligently on this legislation, and I belieye the com- 
mittee has brought forth an excellent legislatiye package. The Senate 



212 



Commerce Committee has been concerned with developing methods to 
control toxic substances for more than 5 years. During this period, 
the committee has held 15 days of hearings and received testimony 
and submissions from numerous experts representing the views of all 
the affected groups. 

Despite the complex nature of this legislation, the Senate Commerce 
Committee was able to report the toxic substances bill unanimously on 
February 17 of this year. In my view, we have reported a tough, fair, 
and comprehensive legislative solution to the ever-growing toxic 
chemical problem in this Nation. 

This legislation requires the Administrator of EPA to carefully 
consider the costs and benefits involved in promulgating rules under 
the testing and restrictive authorities sections of this legislation. These 
provisions will help to insure that regulation under this legislation 
will be constructed so as to impose the least burden on industry and the 
general public [Sec. 6]. 

A prime example of the type of threat to human health and the en- 
viromnent which this bill is intended to prevent is that posed by 
PCB's. This class of chemical is not only toxic but is also exceedingly 
persistent. Once released into the environment PCB's present an ex- 
tremely long-term threat. Furthermore, PCB's are highly concen- 
trated by aquatic life so that fish at the top of the food chain have 
been found with alarming concentrations of PCB residues. There was, 
for example, a serious incident concerning PCB's in my own State of 
Washington in September 1974. An inadequately crated electrical 
transformer containing almost 300 gallons of PCB's was dropped on 
a dock while being loaded for shipping to Alaska. The casing cracked 
and let PCB's leak directly into the Duwamish Waterway. The trans- 
former was allowed to simply sit on the dock for a number of days, all 
the while leaking PCB's into the waterway. 

Toxic substances legislation could greatly reduce or even eliminate 
the chance of this type of incident occurring again. Under this legisla- 
tion, the Environmental Protection Agency would have the authority 
to require that proper precautions are taken in the handling and trans- 
l^ortation of devices containing toxic substances. Furthermore, proper 
labeling could be required with instructions on what to do should any 
accident occur. 

Of course, PCB's are only one example of the type of danger this 
legislation would combat. Our hearings have revealed or examined the 
potential dangers of a multitude of other chemicals, including mer- 
cury, asbestos, vinyl chloride, and fluorocarbons. 

Mr. President, the public has a right to expect that the vast array 
of chemicals that have become an intrinsic part of our daily life have 
been carefully scrutinized to determine whether they are safe. The 
Toxic Substances Control Act will provide this assurance. In closing 
I would like to particularly cite the work of Senators Tunney and 
Hartke concerninir the Toxic Substances Control Act. Their efforts 
Avere extremely valuable in facilitating the progress and development 
of this legislation. I believe they both deserve a great deal of credit. 

The Senator from California mentioned something to the effect that 
we have been very active in the Commerce Committee over the years 
in many of these areas, and I personally am very active as the chair- 
man of the Subcommittee on HEW Appropriations in the cancer 



213 



field. As a matter of fact, the first bill I introduced in the Congress of 
the United States in 1938 as a young Member of the House of Kepre- 
sentatives established the National Cancer Institute. 

But, getting back to this, the Senator from California mentioned 
youngsters. All of us, every member of the Commerce Committee, 
worked hard on the bill that dealt with flammable fabrics. A great 
many kids were being burned up by pajamas and sleep wear catching 
fire. But finally the Commerce Department required of the textile 
people, the manufacturers, that clothing be put on the market w^hich 
is iionfiammable. 

AVell, it turned out that the clothing is nonflammable but it also 
turns out that here is some evidence to the effect that the chemicals 
they put in the cloth to make it nonflammable might cause cancer. We 
are now liaving an investigation of it, and there is pretty clear evi- 
dence. 

If this bill had been enacted — and I know what the delay was about, 
the Senator from California mentioned it, it is well known to the 
Senator from Indiana, about all the problems were had on this, but 
had this bill been enacted, and if the conference the Senator men- 
tioned had reported a bill back to us — there w^ould not be the kind of 
chemicals in the nonflammable fabrics for the kids that there is there 
now. 

I suppose the industry said — "Well, we will put this chemical in 
and it will stop a pair of pajamas or something else from burning up 
and killing the kid or burning him so that he is disfigured and crippled 
for life." But nobody examined what they were going to put into these 
things. 

I understand for the purposes of the Record that they all do not 
use the same chemical, but there are some of them — and the major use 
is what we are talking about. 

So the importance of getting this bill passed and getting it moving 
is that it can apply to all these kinds of problems. It just so happened 
this was called to my attention this week after we had worked a long 
time to get industry finally to develop nonflammable children's wear, 
so that these thousands of kids would not be burned. 

This bill will- provide that when the textile people decide to make 
something nonflammable it is going to have to be tested to see what 
kind of chemical it is going to be and w^hat its other after-effects or 
side effects are going to be. That is just one example of how^ very 
important this bill is. 

I wanted to also say, Mr. President, that I do not know of any bill 
in which I have had the complete cooperation of everybody on the 
Commerce Committee to try to work out this matter. I pay my respects 
to the Senator from California (Mr. Tunney) who worked so hard 
and so long in the hearings; the Senator from Indiana, who did a yeo- 
man's job in trying to solve some of these problems so that the indus- 
tries would accept what we are trvinjr to do; and many others too. 

This is a very imnoi-tant bill. We have always said, and I have al- 
wavs said, down in the Appropriations Committee on HEW, with the 
millions of dollars that were expended for health and for research, 
we have not paid enough attention to what we would call preventive 
medicine, and that runs the gauntlet of everything. 



1 



214 

This is preventive ; that is what it amounts to. I applaud the action 
of the President in taking the leadership yesterday in preventive 
medicine and urging the availability of shots to try to stop a new flu 
epidemic. 

The Senator from Indiana at one time stopped in — and I remember 
this well — when we did not have enough money in HEW and all of 
the doctors said, "We are going to have a rubella epidemic." We put 
some more money in for rubella, and it did not happen. 

Now, this is preventive medicine, and it will do a great deal for 
the health of the Nation. I am so glad that the leadership decided in 
a busy schedule to bring up this legislation because of the importance 
of passing it quickly, if for no other reason than the one I just sug- 
gested. I am sure the Senate is going to respond. 

Mr. Pearsox. Mr. President, S. ^3149, the Toxic Substances Control 
Act, represents a long sought and critically needed piece of legisla- 
tion. Final congressional passage now of this legislation would first, 
come at a time when the need to prevent unreasonable risks of injury 
to health or the environment associated with the manufacture, proc- 
essing, distribution, use or disposal of chemical substances has never 
been greater; second, close an untenable chasm in Federal legislation 
designed to protect human health and the environment, and third, 
culminate over 5 years of congressional consideration of and back- 
ground work on legislation designed to control toxic substances. 

The wide spread introduction and use of new chemicals into our 
daily environment has become a fact of life. It has been estimated that 
there are presently nearly 2,000,000 recognized chemical compounds 
in existence and nearly 250,000 new compounds produced every year. 
Although the vast majority of these compounds are never commer- 
cially produced, the Environmental Protection Agency has recently 
estimated that nearly 1,000 new chemical substances are introduced 
yearly into the marketplace and subsequently find their way into the 
environment. Many of these substances pose unknown and potentially 
high risks to human health and the environment. 

While no one can argue that tremendous benefits have not accrued 
as a result of many of these new chemicals, we have only recently 
begun to recognize that serious human health and environmental haz- 
ards are associated with the use of many of these chemicals. A partial 
listing of commonly utilized and widely dspersed chemicals that have 
been found to pose significant human health and environmental dan- 
gers includes fluorocarbons, PCB's, kepone, vinyl chloride, asbestos, 
mercury, and other heavy metals. Controlling the adverse effects such 
toxic chemicals have upon the environment and human health is per- 
haps the most critical environmental issue facing this Nation. 

This Nation can no longer afford to accept the tragic human suffer- 
ing that has resulted from our continued failure to adequately control 
the manufacture and use of toxic substances. The National Cancer 
Institute has recently estimated that 60 to 90 percent of all cancers 
occurring in this country result from environmental contaminants. It 
is thus not surprising that the highest incidence of cancer is found, 
almost without exception, in large industrial areas where vast quan- 
tities of industrial chemicals are manufactured and consumed. Many 
birth defects and occupational illnesses have also been linked to ex- 
posure to toxic substances. The costs, both in economic and human 



215 



terms, associated with the harmful liealth and environmental effects 
resulting from exposure to toxic substances are simply no longer 
acceptable. Passage of S. 3149 wotild provide a means by which the 
public interest would be protected by assuring that safe and bene- 
ficial chemicals continue to be introduced into the marketplace while 
insuring that these chemical substances that have unacceptable health 
and environmental cost associated with them are properly restricted. 

Existing Federal legislation simply does not provide the means by 
which adverse effects on human health and the environment can be 
ascertained and appropriate action taken before chemical substances 
are first manufactured and introduced into the marketplace. At pres- 
ent, the only remedy available under such Federal statutes as the 
Clean Air Act, the Federal Water Polhition Control Act. the Occu- 
pational Safety and Health Act, and the Consumer Product Safety 
Act, is to impose restrictions on toxic substances after they have been 
first manufactured. The shortcomings in the present system have long 
been evident; corrective action, as evidenced by the Toxic Substances 
Control Act, is long overdue. 

To correct such deficiencies, the Toxic Substances Control Act pro- 
vides the EPA Administrator with authority to require essential and 
critically needed premarket testing of the human healtli and environ- 
mental effects of chemical substances and, where necessary, to regulate 
chemical substances found to present an unreasonable risk to human 
health or the environment. The existence within S. 3149 of a strong 
premarket screening process is a key factor in the effective operation 
of this legislation. We can no longer operate imder the assumption 
that what we do not know alx>ut a chemical substance cannot hurt us. 
Tragic results associated with too many toxic substances have taught 
us that lesson all too well. Chemicals, not people, must be put to the 
test. 

Several key factors concerning S. 3149, in addition to the critical 
provisions regarding premarket review of chemical substances, should 
be noted. First, the bill would represent the only Federal environmen- 
tal statute that would exercise direct control over industrial chemicals 
with respect to their health or environmental effects. Thus increased 
emphasis and attention will be focused on these very important issues. 
Second, the bill provides for an ongoing mechanism that would insure 
that the EPA Administrator would continually have access to new 
information developed regarding adverse health or environmental ef- 
fects associated with chemical substances. He would thus be able, on 
an ongoing basis, to continually evaluate on a timel}^ basis the costs 
and benefits associated with any chemical substance. Third, the bill 
provides for both citizens lawsuits and petitions to insure adequate 
and viable public input with respect to the effective administration 
of the bill. 

I can think of no piece of environmental legislation that is more 
critically needed than S. 3149. I urge my colleagues to strongly sup- 
port this legislation. 

Mr. Hartke. Mr. President, the Toxic Substances Control Act has 
now been pending before Congress for 5 years. This is the third time 
that the Senate will consider the legislation, having passed it twice 
before only to die in conference. 

During the past 5 years, while Congress has struggled to enact toxic 
substances control legislation, the chemical threat has continued to 



216 



grow. For example, approximately 5,000 new chemical substances have 
reached commercial fruition during this period. The hazards asso- 
ciated with chemicals like vinyl chloride, BCME, PCB's, and asbestos 
have all dramatically illustrated how important it is to get early 
warning with respect to new chemical substances and to have the op- 
portunity for gathering test data and taking regulatory action with 
respect to chemicals at the earliest possible time. 

During this 5-year period there have also been in excess of 1 million 
deaths in this country from cancer. Over a million infants have been 
born with physical or mental damage. The latter figure represents 7 
percent of all births. 

Mr. President, it is extremely important that these kinds of statistics 
not continue to mount. While many of the grave health risks to which 
human beings have declined in recent years, cancer statistics have done 
just the opposite. In fact, the incidence of cancer was estimated in 
1975 to be some 21/2 percent above the previous year. 

The National Cancer Institute and the World Health Organization 
have estimated that from 60 to 00 percent of cancer is environmentally 
induced. It is estimated that cancer costs alone in this country exceed 
$18 billion annually. 

It is no accident that the hot spots for cancer in this country are in 
close proximity to those locations where the chemical industry is most 
highly concentrated. For example, excess bladder, lung, liver, and 
ot her cancers among males are all concentrated in those counMes of the 
United States where the chemical industry is most concentrated. 

It is indeed unfortunate that most adverse effects associated with 
chemical substances first appear in the workplace. It is tragic that 
those Avho rely upon the industry for jobs have essentially become 
guinea pigs for discovering the adverse effects of chemical substances. 
It is also tragic that much of the information which has shown the 
cancer producing potential of many chemicals has come from death 
records of employees. For example, of 1 million current and former 
American asbestos Avorkers who still survive, fully 800,000 have been 
projected to die of cancer. This death rate is 50 percent higher than 
that of the United States population at large. 

It is the goal of this legislation to provide a means of preventing 
this suffering and death rather than merely reacting to it or treating 
it medically after the fact. 

One of the chief stumbling blocks in the past which prevented 
agreement between the House and the Senate was the strong Senate 
posit^ion with respect to premarket notification for new chemical sub- 
stances. And the House and Senate seem to be moving together on this 
issue. It is this provision which offers the greatest potential for dis- 
covering the threats from chemical substances at a very early date and 
providing a sufficient data base to take appropriate early action. None 
of the other environmental health statutes, except pesticides and drug 
and food additives law, provide for premarket review by appropriate 
regidatory officials. In fact, this is probably the most important provi- 
sion of the act, for it will enable us to limit chemical threats before 
they become manifest, not after. 

Quite frankly, I had reservations about earlier versions of the Toxic 
Substances Control Act. But in my view, the Committee on Commerce 
acted extremely responsibly in unanimously ordering this legislation 



217 



favorably reported. I am extremely pleased to join the Senator from 
California in being an original cosponsor of the bill reported by the 
Committee. 

In my view, the bill provides all of the essential elements for a proper 
regulatory program. The premarket screening authority will provide 
early warning systems for hazards to health and the environment. The 
bill appropriately limits the authority of the EPA Administrator un- 
der the major regulatory provisions. The bill recognizes other Federal 
authority and provides direction for the EPA Administrator in ad- 
dressing hazards which might be reachable under other Federal 
statutes. 

It is worth dwelling for a brief moment on the economic burdens 
that this legislation might impose and the manner in which the com- 
mittee has addressed these types of concerns. 

There have been widely varying estimates from the chemical indus- 
try of the total cost to the industry of this legislation. Estimates have 
ranged from the Dow Chemical estimate of $2 billion per year doAvn 
to the low estimate of the Manufacturing Chemists Association of $340 
million per year. The Environmental Protection Agency, on the other 
hand, estimated that the total annual cost to the chemical industry 
from this legislation would range only from $80 to $140 million per 
year. 

At the request of the connnittee, the General Accounting Office ex- 
amined these estimates. The GAO report seriously questioned the high 
estimate of Dow Chemical and the Manufacturing Chemists Associa- 
tion and stated that EPA's estimates were more reliable and realistic 
and would cost the chemical industry between $100 to $200 million per 
year. 

It is extremely important to note that in the testing section and in 
the key regulatory sections it is specifically required that the Admin- 
istrator evaluate the risks and benefits of his actions l)efore taking 
action. Thus, costs are not to be incurred unless the Administrator has 
determined they are offset by benefits of at least the same magnitude. 
Obviously it is not feasible to reach these kinds of decisions just on 
the basis of quantitative comparisons and the burdens of human suffer- 
ing and premature death are extraordinary. It is important to note, 
however, that the economic burdens to be imposed by the legislation 
have been recognized and appropriately dealt with. 

Russell Train, Administrator of EPA, has stated : 

It is time we started putting chemicals to the test, not people. It is time we 
gave the people of this country some reason to believe that every time they take 
a breath or eat or drink or touch, they are not taking their life into their hands. 

^Ir. President, I agree wholeheartedly with Mr. Train and I urge 
the Senate to pass S. 3149, the Toxic Substances Control Act. 

Mr. President, I pay special tribute to the chairman of the Com- 
merce Committee for demonstrating humane concern for the health 
of this Nation which is embodied in this legislation. 

I also compliment the Senator from California (Mr. Tunney) who 
has been working on this legislation for all these many years, who con- 
ducted long hearings, frequently doing it in a solitary operation, in 
which he was able to provide for a continued interest in the committee, 
and making sure that we did something affirmatively to control the 
detrimental effect of toxic chemicals in American society. 



79-313 O - 77 - 15 



218 



One think is quite clear from what the chairman has said. We have 
had the help of the people who have been involved in the committee. 
During the markup of the bill the Senator from Kansas again demon- 
strated his effective leadership by helping us out of what appeared to 
be some very difficult situations, and doing it in a rather remarkably 
fast time. Yet at the same time preserving, not only the essential ele- 
ments of the health protection embodied in the bill, but also the pro- 
tection of the individual rights of all the people who could be adversely 
affected. 

A worker himself is directly affected and he has to make that tre- 
mendously difficult choice as to whether or not he is going to work in 
an environment under conditions which might affect his health. He 
knows very well that if he is too critical of what happens inside his 
own operation with regard to the safety and health conditions that 
he may in the long run be cutting his paycheck off. On the other side, 
he knows he may be cutting his life off. 

There is an immediate danger to him. He probably has a tendency 
to go ahead and take the chance on his life because his paycheck is 
needed every Friday night. The difficulty of making sure he has a job, 
and at the same time that he can live with some type of decency, pre- 
sents him with a difficult challenge. 

That is very much a part of what is involved in this bill. 

The other side of the conflict always comes from the industry or 
the business which is involved in manufacturing the chemicals. They 
see themselves perhaps placed in a position where they are dealt with 
rather harshly in an area in which they may sincerely dispute what is 
going on. 

I think the essential element of this legislation is that it has at- 
tempted to provide for the indiA^dual — not only who works, but for 
the rest of American society — ^^the right to know what is in store as 
far as the toxicity of chemicals is concerned. 

The fact of it is that not only do the workers not Imow and the 
general public not know, but in many cases the manufacturers and 
distributors and business people do not know. 

'What we are trying to do here is to provide some type of good judg- 
ment and common sense to improve the quality of American life. 

We have come into an age in which most people, maybe for the first 
time in the history of man, have had a chance to spend some of their 
life in somethinsr other than the mere and sheer operation of trying to 
provide food, shelter and clothing. Yet when we sfet into that type 
position as a result of the technological and scientific age we live in, 
we still find ourselves in the situation where people are suffering the 
adverse aspects of that type of complex and, progressive society. 

I would like to say that this legislation is the type of legislation 
which I think has the essential element of beinir, first, lefifislation 
which we should pass and, second, T hope, legislation which the Presi- 
dent will feel compelled to sign. I hope the House and Senate can join 
hands in making sure the environment of this country is much more 
desirable and that the health of this country is protected. And that as 
far as the working people are concerned, that they no longer have the 
fear and uncertaintv about their workinjj environment. The Nation 
will reap the benefits of having healthier people by merely going 



219 



ahead and, making sure that we know and regulate toxic conditions in 
chemical manufacturing distribution. 

Mr. Tux NET. I wish to say that in response to the comments of the 
chairman of the committee and the Senator from Indiana, there is no 
way, in my view, the legislation could have gotten through either the 
Commerce Committee this year or through the Senate if it had not 
been for the work of the Senator from Indiana. 

The Senator from Indiana was a very important catalyst in develop- 
ing solutions where we had opposition. He was able to achieve ac- 
commodations which in no way kept this legislation from being strong 
and progressive in its regulatory initiatives, but, on the other hand, 
did provide for some changes in the language to keep the bill from 
being oppressive to industry. 

It can certainly be said that the Senator from Indiana played a 
critical role in getting this legislation into the shape it is, which 
makes it more acceptable, in my view, to this body as a whole. 

I also wish to say that the Senator from Kansas, as the ranking 
minority member of the Commerce Committee, played a vital role. 
If it had not been for his cooperation, time and again, I do not think 
we could have had this bill here today. 

I know this to be true because, constantly, he was prepared to rea- 
son with those on the other side of the aisle at a time that lesser men, 
perhaps, would have been satisfied to posture and to make political 
points. 

So the Senator from Kansas and others on the Republican side also 
played a vital role here. 

Mr. Pearson. I thank the Senator. 

Mr. TuNNEY. Mr. President, I have a letter in my hand which I am 
going to have printed in the Record, but I also am going to be quoting 
from it from time to time during the debate — if there should be any 
sharp challenge to the efficacy and legitimacy of this legislation. 

It is a letter from Dow Chemical U.S.A. It appears over the signa- 
ture of Earle B. Barnes. 

But the letter is addressed to a number of different people, perhaps 
30 in number, and it goes on to say : 

Before long we will want to encourage the broadest and strongest possible 
grass roots political action campaign in opposition to Toxic Substances legisla- 
tion. Hopefully, it will be based on mail to and calls on Senators and Representa- 
tives from employees, relatives, friends, distributors, vendors, customers, state 
organizations, etc. The objectives are to kill the bills or to register a minority 
vote sufficient to sustain a hoped-for veto or, as a last resort, to get the bills 
moderated significantly through floor amendments in the House. 

During the past summer we asked for mail to be directed primarily to senators 
because the situation in the Senate was then at a critical stage. The response 
(3,000 or more letters) was very gratifying. Many senators realized for the first 
time that important numbers of their constituents were strongly opposed to 
this largely unnecessary piece of bad legislation. 

Now, the time is near for our big push. We are not alone in this effort. 
Numerous other companies are also rallying grass roots campaigns ; the National 
Association of Manufacturers has taken a strong stand in opposition, and the 
MCA is now stronglv opposed to the two key bills which are, in the Senate, 
S. 776 and, in the House, H.R. 10318. The latter replaced H.R. 7229, H.R. 7548 and 
H.R. 7664. 

So, with all this in mind, you will find the attached package of information 
helpful in extending our request for action to the whole Dow U.S.A. "family" 
plus others. Included are — 

1. Summaries of the two bills in their current state. 



220 



2. Table of Existing Laws showing the overlap of a few present laws with 
key features of the proposed Toxic Substances Control Act. 

3. Representative paragraphs and sentences which people may wish to 
draw uix)n in framing their own letters on their own (non-Dow) stationery. 
We suggest that form letters not be used. 

4. Lists of all Senators and Representatives plus rosters of the two com- 
mittees who have responsibility for this legislation, along with suggested 
forms for addressing letters to Senators and Representatives. 

5. Tips on writing your Representative or Senator. 

Advance briefing and planning sessions will be held with various Government 
Relations managers. Then, we will write, Telex or call them when it is time to 
launch this all-out effort. In the meantime. I hope you will take the necessary 
preparatory action. 

If you need more information, please call me or Chet Otis. 

Thanks for your help, and good luck. 
Very truly yours, 

Earle B. Barnes. 

So Dow Chemical was planning an enthusiastic, spontaneous effort, 
inchidino- prepared para^^raphs which employees could draAv upon, to 
bombard their Senators and Eepresentatives to show that there was 
stronc^ adverse feeling on the part of a representative ^rroup of con- 
stituents. It is this kind of effort, Mv. President, which for the past 5 
years has kept this legislation from goinjr through the Congress and 
being signed into law by the President. 

I think when the kind of activities that they have engaged in are 
exposed, such as they are today by reading this letter into the Record, 
we realize the effort on the part of the Dow Chemical Co., eft at least 
by Mr. Barnes speaking for the Dow Chemical Co., was not to address 
the issue or the issues involved in the legislation based upon reason, 
based upon the merit of the arguments, but simply to use a propaganda 
thrust, a political persuasion which is in no way related to the merits of 
the legislation. 

I think it is this kind of effort which is going to do the industry in 
when it comes to the effectiveness of their approach in trying to block 
the legislation. I think the time has arrived for control of toxic sub- 
stances. Lord knows, the last thing we need is more regulation where 
it is not necessary. 

One of the things that certainly I feel, and many other Senators do. 
is that overregulation of industry can stifle productivity, inhibit crea- 
tivity, and helps to keep the free enterprise system from operating in 
a fashion that it sliould. But when we talk about regulation of toxic 
substances and the prevention of these substances, these carcinogens, 
from getting into the environment, and protecting the health of our 
citizens, there can be no question, in my mind, that any society would 
want to have its government provide the safeguards that this legisla- 
tion does. It is a miracle to me that it has taken so long to get to this 
point. 

Mr. TuxxEY. Mr. President, I send am amendment to the desk and 
ask for its immediate consideration. I offer this amendment for myself 
and Senator Kennedy. 

The A(^TixG PrEvSidext pro tempore. The amendment will be stated. 

The assistant legislative clerk read as follows : 

The Senator from California (Mr. Tunney), for himself, and Mr. Kennedy, 
proposes an amendment. 

The amendment is as follows : 

On page 5, line 7 [sec. 3], immediately following "(vi)" insert "(A)", and 
strike "or" the second time it appears. 



221 



On page 5, line 8, strike "any". 

On page 5, line 10, strike " ( A) ". 

On page 5, line 11. strike "or as any". 

On page 5, line 12, strike "such", and immediately following "(B)" insert "any 
substance". 

On page 5, line 14, strike *"or as any such". 

Mr. TuxxEY. Mr. President, I have sent to the desk a series of 
clarifyin^i' amendments and I ask unanimous consent that they be 
considered en bloc. 

The AcTixG Presidext pro tempore. Is there objection? Without 
objection, it is so ordered. 

Mr. TuNXEY. Mr. President, the amendments are very minor and 
only serve to clarify the manner in which substances used in or on 
foods, drugs, cosmetics, or devices are excluded from the definition of 
a chemical substance. Under the existing language, it is not fully clear 
as to whether substances produced for research and development pur- 
poses and intended only for use in or on foods, drugs, cosmetics, and 
devices were sufficiently excluded. As these substances are now or will 
be covered by the Federal Food, Drug and Cosmetic Act, it is appro- 
priate that they not be covered here. What this amendment does is 
merely to clarify the exclusion that we intended to have written into 
the bill as it came out of the committee. 

Mr. Pearson. Mr. President, this amendment refers to several 
places in the bill, as the Senator indicates, and it is technical in nature. 
We have no objection. 

The AcTix'G President pro tempore. The question is on agreeing to 
the amendment. 

The amendment was agreed to. 

The Acting President pro tempore. Are there any further amend- 
ments ? 

Mr. Helms. Mr. President, I send an amendment to the desk and 
ask for its immediate consideration. 

The Acting President pro tempore. The amendment will be stated. 
The assistant legislative clerk read as follows : 

The Senator frojn North Carolina (Mr. Helms) proposes an amendment: 
Beginning on page 90, line 22 [sec 23], strike out all through line 6 on page 92. 

^Ir. Helms. Mr. President, this amendment would delete the so- 
called employment protection provision of the act, section 23(f), 
Avhich is clearly unnecessary and unwise. It has nothing to do with any 
discussion about toxic substances. 

In the first place, section 23(f) imposes onerous bureaucratic bur- 
dens on both the Environmental Protection Agency and the Employer 
that will unnecessarily increase the costs of administration and compli- 
ance. This section provides that "Any employee who is discharged or 
whose employment is otherwise interrupted, or is threatened with dis- 
charge or such interruption, or otherwise discriminated against by any 
person because of the results of any rule or order issued under this act, 
or a representative of such employee, may request the Administrator to 
conduct a full investigation of the matter." This section provides fur- 
ther that the Administrator "shall hold a public hearing on no less 
than 5 days notice, and shall at such hearings require the parties, in- 
cluding the employer involved, to present information related to the 
actual or potential effect of such rule." 



222 



In other words, Mr. President, this section requires the Adminis- 
trator of the Environmental Protection Agency to conduct a full- 
scale adjudicatory hearing whenever he is requested to do so by any 
employee or employee representative, such as a labor union official, 
who thinks that a ruling issued under the Toxic Substances Control 
Act may endanger his employment, either permanently or tempo- 
rarily. The employer would in turn be required to appear at the hear- 
ing and supply information, with only 5 days notice, relating to the 
effect of a ruling on his employees. The employer, of course, will bear 
the cost of making these appearances, which he will pass along to the 
consumer — and the consumer ought to make no mistake about that — 
and the Federal agency will bear the cost of the hearings, which it will 
pass along to the American taxpayer. 

No matter how you look at it, the American people are going to be 
paying for all of this expensive Federal bureaucratic paperwork, and 
1 submit, Mr. President, that the taxpayers and the small businessmen 
of this country are almost crushed under such a deluge already. 

And what would it all accomplish ? If past experience with similar 
regulatory measures is our guide, the act will simply produce more bu- 
reaucratic harassment of the business community. Employers will un- 
doubtedly be placed on the defensive by the threat of innumerable 
hearings demanding that they justify each and every layoff and em- 
ployment reduction. It requires no great imagination to see that many 
layoffs and employment reductions, whether real or imaginary, will be 
attributed to rulings of the EPA, and that employers will bfe induced 
to keep unnecessary employees in order to avoid bureaucratic proceed- 
ings. The added cost of labor will simply be passed along to the Ameri- 
can people, increasing prices and adding to inflation. 

That is something this country does not need, Mr. President. 

In an industry employing more than a million persons, where some 
1,000 new chemicals are introduced into the market each year, oppor- 
tunities under section 23(f) for initiating these costly proceedings 
seem almost unlimited. 

Xow, contiary to all of the concepts of justice that I understand 
and appreciate! Mr. President, section 23(f) also discriminates 
aorainst the em]:>loyer and denies him equal treatment under the act. 
The manufacturer of a chemical may have his product banned with- 
out being afforded a full, trial-type hearing under the act, but every 
employee who i^eiTeives a possible job layoff must receive a full hear- 
ing, complete with proper adjudicatory procedures. This, frankly, is 
not mv understanding of iustice in the American system of law, Mr. 
President, and I am confident that my colleagues will join with me 
in oposing sec^^ion 23(f) in reco.q-nition of its inequitable features. 

In the second place, section 23(f) is unnecessary because it is dupli- 
cative, lender section 6(c) CI) of the act. the Administrator is re- 
quired to make findings with respect to the economic consequences of 
anv rules of the EPA resrulating chemical substances that are alleg- 
edly, an unreasonable risk to the public health or environment. But 
surely, ^fr. President, one of the most obvious economic consequences 
of any rule is the potential of emplovment reductions: and this is the 
very subject which section 23( f ) commands the Administrator to eval- 
uate constantly and continually. Section 23(f) is thus redundant, in 



223 



the opinion of the Senator from Xorth Carolina, and I believe it should 
be eliminated. 

Mr. President, the principles of fairness, the interests of economy, 
and pride in legislative draftsmanship demand that we delete section 
23(f) from this bill. I urge my colleagues to uphold these standards 
by joining in support of this amendment. I hope that the distinguished 
manager of the bill will agree with me and accept by suggestion. 

Mr. Tux NET. Mr. President. T wish I could find in the amendment 
the merits that I know the Senator from Xorth Carolina feels that it 
has. I would point out to my friend that this language is identical to 
a })rovision in the Water Pollution Act that was passed in 1972 and is 
now on the statute books, and there has been only one case that has 
been brought to the attention of the Connuittee on Commerce in which 
the EPA used its authority, in the 4 years that this statute has been 
on the books, to investigate alleged intimidation against a worker. It 
never even got to the hearing stage. It involved a paper mill in Alaska, 
and ap])arently when the employee made the charge to the Environ- 
mental Protection Agency alleging discrimination by the employer, 
the employer backed down and the man retained his job. 

So thei e has been only one case in 4 years under an exactly similar 
l)rovision in the Water Pollution Control Act. 

Let me tell you what we were trying to obviate by this language in 
this bill. I am going to quote from a letter that was directed to me and 
to another Senator on the committer. It was a handwritten letter, di- 
rected to at least the two of us ; it may have been directed to more. But 
it goes like this : 

I thought that you would like to know of the reaction to S. 776. Toxic Sub- 
stances Control Act. I am in the chemical industry, and there is much pressure 
on us to write and" oppose this hill. In fact, there is downri2:ht intimidation. We 
are asked to write or phone to the committee members, and our names are written 
down by our bosses and the list, in turn, ^nven to their bosses. For what purpose 
I don't know, but a lot of i)eoi)le are afraid not to do as they are told. 

T do not think that this is fair of industry, to put pressure like this on their 
workers, and I would appreciate .someone in the Senate speaking out against this 
form of "support." 

Mr. Hfxms. If the Senator will yield 

^Ir^TuxxEY. .This was written in February, the middle of February 
of 1976. I would be hap])y to yield, but I do liave some other points I 
would like to make. 

^Ir. IIel:ms. Well, will the Senator yield at that point on my time? 

Mr. TrxxEY. Yes. 

^Ir. Helms. The Senator is making a great deal of a company's ef- 
fort to opDose this bill, and I know the Senator is concerned \about 
that, but this is a pait of the political process, is it not ? Labor unions 
do it. but I ha\ e not heard the Senator complain about labor unions 
putting pressure on their members. 

I hear from union members all the time, who say to me : "Senator, I 
agree with you on a ]uece of legislation, but I would catch the devil 
from mv union bosses if I opposed tlieir position.'- So it cuts both ways, 
and I do not think the Senator ought to complain too much about 
efforts bv the biisiness community to o])]:>ose this bill Second, I think 
it is fair to point out that the Senator does not know for certain 
whether the facts of this letter are true : it may have been Avriten by 



224 



an aggravated employee, or someone else. I think that the Senator is 
not justified, if he will forgive me, in stressing the importance of this 
letter. 

The only fact I am pointing out to the Senator, and I say this to all 
of the Members of the Senate, is that if this amendment is not adopted, 
there will be harassment, intimidation, and increased costs, and the 
Senator will hear from it later. This is why I am opposed to this part 
of the bill. 

Mr. TuNNEY. Well, as I have mentioned, in 4 years, under a similar 
provision, there has been one case brought to the EPA, and that did 
not even get to the hearing stage. So I do not quite understand how 
the Senator from North Carolina feels that this is going to result in 
extraordinary cost. I can understand, if we had not had any experience 
under similar legislation, such fears might be reasonable. But with the 
experience that we have had of 4 years under the Water Pollution 
Control Act. I would suggest to the Senator that the empirical evidence 
is such that there is not much merit in the proposition that the Senator 
is makinof today. 

Mr. Helms. I understand what the Senator is sayinof, but I do not 
understand how he relates water to an industry involving the intro- 
duction of a thousand new substances a year, each of which could 
have an effect along the lines that we are discussing here. 

Mr. President, T ask for the yeas and nays. 

The PREsroiNG Officer (Mr. Nelson). Is there a sufficient second? 
There is a sufficient second. 

The yeas and nays were ordered. 

Mr. Pearson. Mr. President, will the Sen tor yield for a question ? 
Mr. Helms. Yes. 

Mr. Pearson. I wonder if the Senator intends in his amendment to 
strike subparagraph 1, starting at line 22 on page 90 [sec. 
23(f)(1)]. I am advised that there is in another part of the bill a 
requirement of the Administrator to make an evaluation of the eco- 
nomic impact of this particular legislation. That is general in nature. 
This is meant to be specific or enforcing language. It has provisions 
as to continuing economic implications, the shifts and reductions of 
employment, and so forth, under the rules and under the act. 

We are advised that that particular subparagraph is one in which 
industry is very vitally concerned. I wonder if the Senator feels that 
that also is a matter which should be striken out in his amendment. 

Mr. Helms. Mr. President, will the Senator identify the section to 
wliich he refers ? 

Mr. TuNNEY. Section 23(f) assures that the Administrator of 
EPA Avill assess the job impact resulting from the issuance of any rule 
or order under the Toxic Substances Control Act, and that is what the 
Senator from Kansas was referring to when he indicated that this is 
desirable from the point of view of industry, because we should not 
have an administrator issuing: rules that could result in the layoffs of 
hundreds or maybe thousands of persons without evaluating that im- 
pact upon t]ie workers and upon the community in which they work. 

The Administrator also, under the provision, will in appropriate 
circumstances investigate allegations that employers are discriminat- 



225 



intr ai^ainst employees as a result of any rule or order issued under 
the act. 

I tliink that the Senator in his amendment is really referring to this 
portion of section 23(f). Section 23(f)(2) clearly states that the 
EPA will only investigate, hold a hearing on an employee's complaint, 
and make findings of fact. 

Therefore, the Administrator is required to take this action if he 
believes that an employee complaint of alleged employment effects is 
"because of the results of any rule or order issued under the act." 

I might point out that the Administrator can hold a hearing, and 
make findings of fact and that is it. He can publicize the results of the 
hearings, but he cannot order the employer to reinstate the employee 
under subsection (f). I think that the manager of the company 
ought to take the heat that comes with public exposure of that kind 
of discrimination. 

Mr. Helms. Mr. President, I ask for the yeas and nays. 

Mr. TuxxEY. The yeas and nays have been ordered. 

The Presidixg Officer. All time is yielded back. The question is 
on agreeing to the amendment of the Senator from North Carolina. 
The yeas and nays have been ordered, and the clerk will call the roll. 

The assistant legislative clerk called the roll. 

Mr. Robert C. Byrd. I announce that the Senator from Indiana 
(Mr. Bayh) , the Senator from Texas (Mr. Bentsen) , the Senator from 
Delaware (Mr. Biden), the Senator from Mississippi (Mr. Eastland), 
the Senator from Alaska (Mr. Gravel), the Senator from Michigan 
(Mr. Hart), the Senator from Colorado (Mr. Haskell), the Senator 
from Hawaii (Mr. Inouye), the Senator from Washington (Mr. 
Jackson), the Senator from Arkansas (Mr. McClellan), the Senator 
from Wyoming (Mr. McGee), the Senator from South Dakota (Mr. 
McGovern), the Senator from New Hampshire (Mr. Mclntyre), the 
Senator from New Mexico (Mr. Montoya), the Senator from Utah 
(Mr. Moss), the Senator from Mississippi (Mr. Stennis), and the 
Senator from Missouri (Mr. Symington), are necessarily absent. 

I also announce that the Senator from Vermont (^Ir. Leahy), and 
the Senator from Louisiana (Mr. Long), are absent on official 
business. 

I further announce that, if present and voting the Senator from 
Washinirton (Mr.- Jackson) , would vote "nay". 

Mr. To^\T!:r. T announce that the Senator from Tennessee (Mr. 
Brock), the Senator from Massachusetts (Mr. Brooke), the Senator 
from New York (Mr. Buckley), the Senator from Arizona (Mr. Fan- 
nin), the Senator from xVrizona (Mr, Goldwater), the Senator from 
Michigan (Mr. Griffin), the Senator from Oregon (Mr. Hatfield), the 
Senator from Nebraska (Mr. Hruska), the Senator from Nevada (Mr. 
Laxalt), the Senator from Marydand (Mr. Mathias), the Senator 
from Pennsylvania (Mr. Hugh Scott), the Senator from Virginia 
(Mr. William L. Scott), the Senator from Vermont (Mr. Stafford), 
and the Senator from Connecticut (Mr. Weicker), are necessarily 
absent. 

I further announce that, if present and voting, the Senator from 
Oregon (Mr. Hatfield), and the Senator from Pennsylvania (Mr. 
Hugh Scott) , would each vote "nay." 



226 



The result was announced — ^yeas 13, nays 54, as follows : 





rRnllrall Vntp Nn 102 T-pp- 1 










Allen 


Helms 


Taft 


Bartlett 


McClure 


Thurmond 


Byrd, Harry F., Jr. 


Morgan 


Tower 


Curtis 


Sparkman 


Young 


Hansen 






NAYS— 54 




XI. Lfi^ u 1 tr^ Jv 


if ong 


iM eioon 


Baker 


Tfnrri 
J? iJL u 


Nunn 


"ROQ 11 


Garn 


Packwood 


Bellmon 


^jrienn 


Pastore 




xid.rL, vjrdry 


1: earsou 


JjUrUlCK 


xiarLKe 


Piiii 
r^eii 


xsyra, xvODeru kj. 


Hathaway 


Percy 




XlOlllUgb 


Proxmire 


Case 


riuutiiebLon 


Randolph 


Chiles 


Humphrey 


Ribicoff 


Church 


Javits 


Roth 


v-'iarK 


Johnston 


Schweiker 


Cranston 


Kennedy 


Stevens 


Culver 


Magnuson 


Stevenson 


Dole 


Mansfield 


Stone 


Domenici 


Metcalf 


Talmadge 


Durkin 


Mondale 


Tunney 


Eagleton 


Muskie 


Williams 




NOT VOTING— 33 




Ddy 11 


ULciL I., X llllljj xx. 


ivxnjree 




indbKeii 


iVX L vjr (J V c 111 


Biden 


XldLUtflU. 




Brock 


Hruska 


Montoya 


Brooke 


Inouye 


Moss 


Buckley 


Jackson 


Scott, Hug] 


Eastland 


Laxalt 


Scott, Will 


Fannin 


Leahy 


Stafford 


Goldwater 


Long 


Stennis 


Gravel 


Mathias 


Symington 


Griffin 


McClellan 


Weicker 



So Mr. Helms' amendment was rejected. 

The Presidixg Officer. The Senator from New Jersey is recognized. 

Mr. Tunney. Mr. President, will the Senator yield? I ask for the 
yeas and nays on final passage. 

The PREsroiNG Officer. Is there a sufficient second ? There is a suf- 
ficient second. 

The yeas and nays were ordered. 

Mr. Case. Mr. President, I have an amendment at the desk, on be- 
half of myself and my colleague. Senator Williams, and I ask that 
it be reported, but may it be reported in the form which I now hand 
to the desk. 

The Presiding Officer. The clerk will report the amendment. 
The second assistant legislative clerk proceeded to read the amend- 
ment. 

The amendment is as follows : 

On page 93, between lines 8 and 9, insert the following new section : 



227 



STATE DEMONSTRATION PROGRAMS 

Sec 25(a). Establishment of Program. — The Administrator is authorized to 
assist no more than three states in estahlishing demonstration. Programs by sueli 
states to protect against unreasonable risks to liealth or the environment asso- 
ciated with chemical substances and mixtures. Such programs sliall — 

(A) identify and inventory chemical substances and mixtures within such 
state, including their manufacture, processing, distribution, use, and 
disposal : 

(B ) monitor the extent to which such chemical substances or mixtures are 
present in the environment of any such state and the human exposure to 
such substances or mixtures within such state : 

(C) establish a program to (1) prevent or eliminate unreasonable risks to 
health or the environment presented by chemical substances or mixtures 
Hi) integrate the control of chemical substances and mixtures under this 
section with other programs of environmental and public health protection 
within such state so as to appropriately minimize the overall pollution of 
the environment within such state: and (iii) identify the appropriate gov- 
ernmental institutions and processes neces.sary to implement a program for 
the prevention of unreasonable risks to health or the environment presented 
by chemical substances and mixtures ; 

(D) analyze and evaluate the results of such programs through annual 
reports to the Administrator ; and 

(E) complement and in no way reduce Federal efforts under this Act in 
such state. 

(b) Reports. — The Administrator shall .«<ubmit a report to the appropriate 
committees of Congress not later than July 1 of each calendar year. Such report 
shall include (1) a description of progress with respect to programs assisted 
under this section and any suggestions for improvement in such program. (2) 
recommendations as to the manner by which programs within the states for the 
prevention of unrea.sonable risk to health or the environment presented by chem- 
ical substances may fea.^ibly be implemented, and (3) the extent to which the 
Administrator has disseminated information regarding programs authorized 
under this section to other interested .states and other i)ersons. 

(c) Authorization for Appropriations. — For the purposes of providing a.ssist- 
ance under this section, there are hereby authorized to be appropriated not to 
exceed -$2,0()0,00() for the fi.scal year ending September 30. 1977: $2,000,000 for 
the fiscal year ending September 30, 197S, and .$2,000,000 for the fiscal year 
ending on September 30, 1970. Any funds appropriated under the authority of 
this subsection shall remain available until expenderl. Funds available imder 
this section shall not be available for programs which would duplicate any au- 
thority or requirements of the Administrator under this Act. including sections 
4, 5, 6 and 9(c). Funds available under the authority of this section shall support 
not more than 75 percent of the costs of any .such program described under sub- 
section (a) engages in by the State . 

(d) Priorities. — Assistance afforded under this section shall be available 
(subject to the requirements of subsection (a) ) to those states which can estab- 
lish a priority need for such assistance, as determined by the rules of the 
Administrator. In establishing such rules, the Administrator shall consider the 
existence of serious health effects associated with chemical substances within 
such state including cancer, birth defects, and gene mutations : the extent to 
which chemical substances and mixtures are manufactured, processed, distrib- 
uted in commerce, used and disposed of within such state : and the extent of 
exposure of human beings and the environment to chemical .substances and mix- 
tures within such State. The Administrator shall approve all such programs and 
establish a mechanism for monitoring such programs. 

(e) DIscLAI^rER.— Nothing contained in this section shall affect any provision 
of section 18 of this Act. 

^Ir. Case. ]Mr. President, the amendment we propose would be of 
significant benefit in implementing the mandates of the Toxic Sub- 
stances Control Act. It would enable selected States to develop demon- 
stration programs to protect against unreasonable risks to health or 
the environment associated with chemical substances and mixtures. 



228 



Through a demonstration program, States like New Jersey could 
obtain the data necessary to make reasoned decisions as to the dangers 
to humans resulting from exposure to toxic substances. It would also 
provide the basis for State management measures to be proposed in 
the demonstration States and elsewhere. Especially important, it 
would coordinate State programs with Federal programs, demonstrat- 
ing methods to minimize the burden upon industry in the require- 
ments for submission of information and data to the several levels of 
government that are involved in toxic and other environmental 
programs. 

Our amendment would provide for State demonstration grants in 
no less than one, and no more than three States. The key elements of 
such State ])rograms would be : 

First, to identify and inventory chemical substances and mixtures in 
the State at various stages in their cycle of use ; 

Second, to monitor the extent to which such chemical substances or 
mixtures are present in the environment of such State, and the extent 
to which human beings in that State are exposed to them ; 

Third, to establish a State program that would prevent or eliminate 
unreasonable risks to health or the environment from chemical sub- 
stances of mixtures, to integi-at-e toxic substances management pro- 
grams with other environmental and public health programs so as to 
minimize the overall pollution of the State's environment, and to 
identify the appropriate governmental institutions and processes nec- 
essary to implement such a program. 

This point is of particular importance. For too long we have seen 
pollution control technologies which merely serve to transfer the prob- 
lem from one medium to another — such as air pollution technologies 
which remove contaminants from the air and put them into the water 
cycle instead. This is hardly a solution. 

Fourth, to analyze and evaluate the results of such programs through 
annual reports to the Administrator of EPA. 

The Administrator of EPA, in turn, must submit annual report 
to the Congress on the progress of the demonstration projects, recom- 
mended ways for other States to implement toxic substances manage- 
ment programs, and recommend additional legislation if necessary. 
The Administrator's report must describe the extent to which he has 
disseminated the information derived from the demonstration pro- 
grams to other interested States and persons. 

This is not a demonstration program to be funded and then forgot- 
ten. EPA will be under a mandate to study, evaluate, and make known 
what has been learned from the demonstrations, so that others will 
benefit. 

There is authorized for each fiscal year, 1977, 1978, and 1979, $2 
million, with the Federal share of the program not to exceed 75 
percent. 

There are explicit provisions that these funds will not be used to 
duplicate other requirements and programs. As I stated earlier, one 
of the primary objectives of this demonstration program is Federal- 
State coordination so as to minimize tlie burdens on industry. 

Other amendment would give priority for grants under this section 
to those States where the problem of the effects of toxic substances 
are most acute. Specifically, the Administrator's project selection must 



229 



consider: First, the existence of serious health effects associated with 
chemical substances within such State, including cancer, birth defects, 
and gene mutations ; second, the extent to which chemical substances 
and mixtures are manufactured, processed, distributed in commerce, 
used and disposed of within such State ; and third, the extent of ex- 
posure of human beings and the environment to chemical substances 
and mixtures within such State. 

Finally, this amendment assures that nothing in this new section 
increases or decreases the authorities of a State, as established under 
section 18, preemption. 

New Jerseyans were shocked to learn earlier this year that our 
State has the highest rate of cancer in the country, not for one, but 
for all types of cancer. We were totally unprepared for this news. 

We know that exposure to certain chemicals can cause cancer, but 
there remain many, too many, unanswered questions. We need to 
identify- these chemicals, find out what qualities of them pose a hazard, 
and — most important — we nuist find out what we can do to reduce the 
risk to Xew Jerseyans. 

It seems to us that adoption of tliis amendment to the toxic sub- 
stances bill would provide the means to find answers to these questions. 

This amendment would be of great significance in helping our State 
and other States with similar problems to develop demonstration pro- 
grams to protect against imreasonable risks to health or the environ- 
ment associated with chemical substances and mixtures. It provides 
for demonstration programs with Federal participation jointly with 
the States. It authorizes $2 million a year for 3 years, and the States 
must participate to the extent of 25 percent. 

I understand that the amendment is agreeable to the minority and 
the majority. 

Mr. Williams. Mt. President, I am pleased to join with Senator 
Case in offering this amendment to the Toxic Substances Control Act. 
The amendment would autliorize the FPA to establish up to three 
State demonstration programs in selected States to complement the 
Federal toxic substances conti-ol program. The State programs would 
in no Avay reduce or replace F'ederal efforts to control toxic substances 
under the act. The demonstration programs would allow a State to 
inventory chemical substances within its borders and monitor the ex- 
tent of human and environmental exposure to these substances. 

The State would be required to integrate its program for controlling 
toxic substances witli other State environmental and public health pro- 
grams, and to coordinate its efforts with those of other levels of goA'- 
ernment. By requiring the coordination of State and Federal efforts 
to control toxic substances, the amendment would help to reduce 
duplicative regulation. It would help to create greater stability of 
expectations in industry and end the arbitrary and often conflicting 
requirements inij^osed by various authorities which have adverse effects 
on investment decisions. 

Senator Case and I represent a State where the need for such a pro- 
gram is manifest. Xew Jersey has both the highest concentration of 
chemical plants and the highest cancer death rate in the Nation. Ac- 
cording to the National Cancer Institute, this is no coincidence. A 
study done by the National Cancer Institute found a high correlation 
between cancer deaths and densely concentrated industry. New Jer- 



230 



sey's 21 counties were found to be in the top 10 percent of all counties 
in the Nation for the rate of cancer deaths. Salem County, N.J., where 
25 percent of the males work in the chemical industry, has the Na- 
tion's highest rate of bladder cancer — an occupational disease associ- 
ated with chemical exposure. These figures are no less than alarming. 
This legislation and this amendment together address this critical mat- 
ter in a comprehensive and coordinated way. 

The immediate need at the State level is to begin to determine the 
types and quantities of toxic substances already present in the environ- 
ment. This cannot be done with the monitoring systems already in 
place. EPA would collect the data on various chemical substances, but 
it would be up to the State to follow these substances through the 
circle of their use — manufacture, processing, distribution, use, and 
disposal. While the amendment will not give the States any authority 
to regulate workplace exposures or duplicate any authority under the 
Occupational Safety and Health Act, information gathered under the 
amendment could complement Federal efforts under OSHA. 

Like most other States, New Jersey now^ has an extensive monitor- 
ing network in both air and water. These systems are designed to 
monitor the air and water for so-called classical pollutants. This net- 
work is the major method by which New Jersey's Department of En- 
vironmental Protection has been able to define the extent of the State's 
environmental problems, as well as improvements in environmental 
quality. 

But for toxic substances, new monitoring stations must be estab- 
lished according to different criteria, and analytical techniques must 
be utilized which are much more complex and time-consuming than 
those currently utilized. 

The results of such a State demonstration program would be eval- 
uated at both the State and Federal level and would be used as a model 
for other States to build their own programs. 

The final result of such a demonstration program, it is hoped, would 
be to reduce the rate and prevalence of cancer and other environmen- 
tally related diseases. 

Mr. TuNNEY. I am authorized by my distinguished friend from 
Kansas (Mr. Pearson) to indicate that this amendment is acceptable 
to both the minority and the majority on the committee. This is an 
amendment that will allow States the leeway in certain circumstances 
to structure programs to meet particularly acute local and regional 
problems and, therefore, I am prepared to yield back the remainder 
of my time. 

The Presiding Officer. All time yielded back. The question is on 
agreeing to the amendment of the Senator from New Jersey. 
The amendment was agreed to. 

Mr. Case. Mr. President, I move to reconsider the vote by which the 
amendment was agreed to. 

Mr. TuNNEY. I move to lay that motion on the table. 
The motion to lay on the table was agreed to. 

Mr. Allen. Mr. President, I call up an amendment which I have 
at the desk. 

The Presiding Officer. The amendment will be stated. 
The second assistant legislative clerk proceeded to read the amend- 
ment. 



231 



The amendment is as follows : 

On page 9, line 2, [Sec 3], after the period add the following : 

"(15) The term 'unreasonable adverse effects on the environment' means any 
unreasonable risk to man or to the environment taking into account the economic 
social, and environmental costs and benefits of the use of any chemical sub- 
stance." 

On page 52, line 5, strike out all after the word "show" down to and includ- 
ing the period at the end of line 11 on page 52 and substitute in lieu thereof 
the following : "that a situation exists in v. hich the continued use of a chemical 
substance would be likely to result in unreasonable adverse effects on the en- 
vironment or will involve an unreasonable hazard to the survival of a species 
declared endangered by the Secretary of the Interior under Public Law 91-135." 

Mr. Allen. Mr. President, the amendment I have introduced is de- 
signed to 2)rovide the Administrator of the Environmental Protection 
Agency with the same definition of "imminent hazard'' and ''unrea- 
sonable adverse effects'' in the Toxic Substances Control Act as are 
contained in the existing law which regulates tlie testing and registra- 
tion of pesticides, the Federal Insecticide, Fungicide, and Rodenticide, 
Act, as amended, Public Law 92-516 and Public Law 04-140. My 
amendment does not in any way weaken the ability of the Adminis- 
trator to restrict the use of toxic chemical substances but it would 
provide tlie consistency neded for even-handed administration of two 
laws, both of which would have the same intent and both of wliich 
w-ould regulate in most instances the same industries and essentially 
the same subject matter. 

Mr. President, when the legislation which led to the Federal Lisec- 
ticide, Fungicide, and Rodenticide Act was first introduced in the 
Senate, it was referred jointly to the Senate Committee on Commerce 
and to the Senate Committee on Agriculture and Forestry. This joint 
referral evidenced the dual jurisdiction which exists with respect to 
legislation affecting the chemical industry. I would remind Senators 
in this connection that Senate rule XXV 1(b) specifies that all pro- 
posed legislation relating to ''agricultural and industrial chemistry" 
shall be referred to the Committee on Agriculture and Forestry. Al- 
though no similar language is contained in rule XXV 1(f) which sets 
forth the jurisdiction of the Senate Committee on Commerce, very 
properly committee jurisdiction over the legislation which led to the 
enactment of the Federal Insecticide, Fungicide, and Rodenticide Act 
was shared with the Committee on Commerce. Mr. President, regret- 
tably such was not the case in the present instance. Had committee 
jurisdiction over toxic substance control legislation been likewise 
shared. I am confident the inconsistencies between the bill reported 
by the Senate Committee on Commerce and existing laws could have 
been eliminated without the necessity of extensive floor amendment. 

Mr. President, I believe it is vitally important that S. 3149. the 
Toxic Substance Control Act, if enacted, be consistent wdth existing 
law in the standards to be used by the Administrator and his staff in 
administerinfr the law regulating the use of chemicals. The adminis- 
trator and his staff have had the opportunit}^ to apply the existing 
standards contained in the Federal Insecticide, Fungicide, and Ro- 
denticide Act in actions taken by the Agency in regulating the regis- 
tration and use of pesticides. It would not seem prudent or logical 
for the Agency, which would be responsible for the administration of 
two separate laws governing toxic chemicals, to be saddled with con- 
flicting language in the two laws. 



232 



I recently had occasion to preside at 4 days of hearings before the 
Senate Subcommittee on Agricultural Eesearch and General Legisla- 
tion of the Senate Committee on Agriculture and Forestry during the 
course of that subcommittee's investigation of the kepone contamina- 
tion of the James Kiver in the vicinity of Hopewell, Va. During those 
hearings I became somewhat familiar with the composition and use of 
the pesticide kepone. It should be no revelation that toxic chemicals 
are used as components of agricultural poisons, such as kepone, or that 
pesticides are themselves often components of toxic substances which 
are manufactured for entirely different uses. The questions at issue 
in examining the use or registration of pesticides, fungicides, and 
rodenticides, therefore, differ little if at all from those posed with 
respect to other toxic substances. 

Many manufacturers avIio are producing pesticides are also produc- 
ing other toxic chemical compounds, and it would be confusing and 
frustrating for a manufacturer of chemical substances to be subjected 
to two different standards or requirements. For example, any chemical 
or toxic substance would first be subject to the provisions of this act, 
and yet when it becomes a component of a pesticide, it would be subject 
to FIFRA. In many instances, the manufacturer of the component is 
also the manufacturer and registrant of the pesticide. It is unreason- 
able to expect either the Administrator or the manufacturer to carry 
out properly their responsibilities in the presence of conflicting legis- 
lative language regulating chemical substances. 

Throughout the bill, numerous references are made to "unreasonable 
risk" without providing a definition of the term. The term is also used 
in connection with other qualifying phrases which have dissimilar 
connotations and which could create problems and confusion in the 
administration of the two statutes. These phrases include: 

"Cause or contribute to an unreasonable risk of injury to health or 
the environment'" ; "present an unreasonable risk to human health and 
the environment"; and "is likely to present an unreasonable risk to 
health or the environment." 

^ly amendment would provide that, w^henever the term "unreason- 
able risk" is used it will be in accord with the meaning of "unreason- 
able adverse effects" as defined in my amendment and as defined in the 
Federal Insecticide, Fungicide, and Rodenticide Act. Similarly, and 
for the same reasons, the definition of "imminent hazard" is brought 
in line with the definition of that term in the Federal Insecticide, 
Fungicide, and Rodenticide Act. 

Mr. President, I am convinced that consistency is a desirable goal in 
the regulation of the use of chemical substances. Since my amendment 
would not in any way weaken the Administrator's authority in regu- 
lating those uses, I urge that the amendment be adopted. 

Mr. President, the rules state, specifically rule XXY states, that 
all legislation relating to agriculture and agricultural chemistry 
should be within the jurisdiction of the Agriculture Committee. To 
that end kgislation having to do with FIFRA, the Federal Insecticide, 
Fungicide, and Rodenticide Act, having to do with pesticide legisla- 
tion has always gone to the Agriculture Committee. 

This bill, however, was not referred jointly to the Commerce and 
Agriculture Committees. I believe that the Agriculture Committee, if 
it had had the bill referred to it, would have made as its main con- 



233 



tribution the reconciling of the rules with respect to the application of 
the rules ^roverning the toxic substances to the FIFRA legislation so 
that the EPA, in administering two a ery closely related acts, would 
not have different definitions in connection with their enforcement. 

All this amendment does is to conform the definitions in the toxic 
substances bill to the established definitions under the FIFRA legisla- 
tion which has served the EPA well and under which it now operates. 

I believe the amendment is satisfactory to the manager of the bill. 
I have discussed it with him, and I am hopeful that he will endorse 
the amendment 

Mr. Tux NET. The Senator from Alabama has, in my view, stated the 
situation correctly, that his amendment is merely an amendment which 
makes the language in this legislation conform with the Pesticides 
Control Act as it relates to the imminent hazards, and I think it is 
important that we do have on the statute books language such as the 
Senator from Alabama has suggested. 

Mr. Talmadgk. I commend the Senator from Alabama for intro- 
ducing his amendment, and I commend the distinguished manager 
and his counterpart, the Senator from Kansas, for accepting it. I 
think it is important to have toxic substances and pesticides measured 
by the same yardstick. That is what the Senator's amendment would 
do. 

Mr. TuNNEY. I thank my friend from Georgia, and I agree with his 
statement. I think we should have the same yardstick in various 
statutes. 

Mr. Pearson. Mr. President, we find the amendment conforming 
and we accept it. 

The Pr?:sii)ing Officer. The question is on agreeing to the amend- 
ment of the Senator from Alabama. 
The amendment was agreed to. 

Mr. Nelson. INfr. President, I send an amendment to the desk and 
ask for its immediate consideration. 

The Presiding Officer. The clerk will report the amendment. 

The second assistant legislative clerk proceeded to read the amend- 
ment. 

The amendment is as follows : 

On page 64, line 13 [Sec 10], insert immediately after the period, "In accord- 
ance with s\uh responsibilities, the Administrator shall undertake and supi)ort 
programs of research and monitoring of polyehlorinated biphenyls to the extent 
necessary to develop safe methods of disjjosal of polyehlorinated biphenyls and for 
the control of risks of injury to health or the environment associated with poly- 
chh)rinated biphenyls," 

On page 52, between lines 2 and 3 [Sec. 6], insert the following new subsection : 

"(e) I'oLYCiiLORiNATED BIPHENYLS. (1) Effective 1 year after the date of 
enactment of this Act, it shall be unlawful to manufacture, process, distribute 
in connnerce. or use any polyehlorinated biphenyl in any manner other than in 
a totally enclosed manner, except that the Administrator may, by rule promul- 
gated in accordance with subsection (o){2), authorize the manufacture, proc- 
essing, distribution in commerce, or use of any polyehlorinated biphenyl in other 
than a totally enclosed manner if the Administrator finds that no unreasonable 
risk of injury to health or the environment is presented. 

"(2) Effective 2 years after the date of enactment of this Act, it shall be 
unlawful to manufacture any polyehlorinated biphenyl, and effective 21/2 years 
after such date, it shall be unlawful to process or distribute in commerce any 
polyehlorinated biphenyl, except that the Administrator may authorize, by rule 
promulgated in accordance with subsection (c) (2), such manufacture, processing, 



79-313 O - 77 - 16 



234 



or distribution in commerce after such time period if the Administrator finds 
that no unreasonable risk of injury to health or the environment is presented. 

"(3) Within 6 months after the date of enactment of this Act, the Adminis- 
trator shall promulgate rules under subsection (a) which shall (A) prescribe 
methods for the disposal of poly chlorinated biphenyls in accordance with the 
requirements of that subsection and (B) specify the manner in which poly- 
chlorinated biphenyls shall be marked with clear and adequate warnings and 
instructions with respect to their processing, distribution in commerce, use, or 
disposal. Any such rules shall be consistent with the requirements of paragraphs 
(1) and (2) of this subsection or rules issued thereunder. 

"(4) For the purposes of this subsection, the term 'totally enclosed manner' 
means any manner which will ensure that any leakage of a polychlorinated 
biphenyl from its enclosure will be insignificant, as defined in rules of the 
Administrator." 

On page 71, line 13 [Sec. 151, immediately following "5" insert "or 6." 

Mr. Nelson. Mr. President, this amendment provides over a period 
of time the elimination of the use in open or closed systems of PCB's, 
polychlorinated biphenyls, unless the EPA administrator finds that 
there is not a serious health hazard. 

He also has to weigh, of course, under the provisions of the statute, 
the question of cost-benefit ratio. 

It is my understanding that the manager of the bill and Senator 
Pearson are acquainted with the proposed amendment and find it 
acceptable. 

Mr. President, it has become clear that PCB's present a serious 
pollution problem. 

Therefore, I am offering this amendment. 

First. It bans the manufacture, processing, distribution and use of 
nonenclosed PCB's 1 year after enactment, \mless the Administrator 
of the Environmental Protection Agency — EPA — finds there is no 
tnireasonable risk of injury to health or environment from continuing 
such uses. These include: uses in carbonless paper, paints, coatings, 
soaps, and copying ink toners. 

Second. The manufacture of all PCB's would be banned effective 2 
years from the date of enactment ; and the processing and distribution 
of all PCB's would be banned 6 months after that— 21/2 years after 
enactment — unless the administrator finds that no reasonable risk of 
injury to health or the environment is presented by PCB's. This would 
effectively ban all PCB use, including closed uses, such as in electrical 
capacitors and transformers. 

Third. Within 6 months after enactment, EPA is required to issue 
regulations for the first, disposal of PCB's and second, labelling Avith 
warnings and instructions of all products containing PCB's with 
respect to their use and disposal. 

Fourth. The amendment defines "totally enclosed manner" so as to 
insure that "any leakage of a PCB from its enclosure will be insig- 
nificant, as defined in rules" by EPA. 

All imported PCB's would be subject to the same restrictions. 

This amendment is patterned after one that I introduced on Decem- 
ber 19, 1975, which Senator Bumpers joined in sponsoring. 

Under the. amendment, the continued use of PCB's would be allowed 
if the EPA Administrator finds that "no unreasonable risk of injury 
to health or the environment" exists. In making such a finding, it is 
implicit that consideration be given to the availability of substitutes 
for PCB's, presumably having less risk. 



235 



In addition, to the extent that PCB's continue to be authorized for 
use, it is assumed that EPA Avill regulate any recycling of them. 

Mr. President, scientific evidence makes it imperative that we no 
longer wait to regulate and eliminate this toxic substance. The risks 
to human health and the environment appear to exceed the benefits of 
these substances, which, like DDT, are not readily biodegradable and 
tend to accumulate in the food chain. 

According to a report on PCB's prepared by the Legislative Re- 
search Service, Library of Congress : 

PCBs have been used extensively in industry for a variety of applications for 45 
years. Until the mid Sixties, it was not fully recognized that large amounts of 
PCBs were escaping into the environment and that the substance might cause 
hazard to human health and the environment. High levels of PCBs are now found 
in carnivorous fish taken from the Great Lakes and some other areas. Levels are 
so high, in fact, that serious doubts have been raised over the safety of humans 
consuming these fish. Sports fishing programs, such as the Coho Salmon restock- 
ing projects in the Great Lakes and the commercial fishing industry in these areas 
are at stake. PCBs are found at low levels in human adipose tissue in all parts of 
the country, illustrating how pervasive and widespread the pollution has become. 

"Although Monsanto, the sole United States producer of PCBs, has voluntarily 
limited PCB sale to a few companies for use in electrical closed systems, the 
problem of more PCBs entering the environment through these routes, from exist- 
ing equipment containing PCBs, and from imported stocks, still exists. It has 
been suggested that PCB use be totally eliminated in the United States, or al- 
ternately, that its use be more tightly controlled. 

The Library report further notes : 

The possibility of adverse effects upon human health from PCBs was high- 
lighted in October of 1968. In the Fukuoka prefecture in western Japan, acci- 
dental contamination by PCBs of edible rice-bran oil caused an outbreak of toxic 
symptoms, the "Yusho" poisoning incident. Soon afterward. PCBs were detected 
by the U.S. Food and Drug Administration (FDA) in milk, poultry, and other 
foods due to accidental leakage of PCBs from machines and PCB food packag- 
ing made from recycled paper, and in fish exposed to PCBs in the environment. 

Action (tolerance) levels for PCB contamination of food. feed, and food pack- 
aging were established by FDA. The EPA initiated a test program and moni- 
toring of PCB levels in the environment and proposed regulations governing the 
discharge of PCBs into waterways as an industrial effluent (under the Clean 
Water Act). Meanwhile, on the state level, actions were taken against point 
source discharges of PCBs. 

The widespread occurrence of PCBs in the environment, the bioaccumulation 
of PCB in the food chain of fish found in the human diet, and the persistence of 
the chemical compounds assure that PCB environmental contamination will con- 
tinue to be a problem for many years to come. 

Here are the facts : 

PCBs have been found, in scientific tests, to cause severe skin and liver prob- 
lems in humans. University of Wisconsin Medical School researchers Dr. James 
R. Allen and Deborah Barsotti. have demonstrated that very low PCB levels are 
dangerous to primates, causing facial swelling, loss of hair, acne lesions within 
one month, birth defects, miscarriages, stillbirths, and death. 

A 1972 report by a Federal interdepartmental task force urged a ban on all 
PCB uses except in closed electrical systems, restricting them to "essential or 
nonreplaceable uses which involve minimum direct human exposure, since they 
can have adverse effects on human health." 

The commercial fishing industry in the Great Lakes and elsewhere are threat- 
ened with extinction, unless the PCB problem can be alleviated or eliminated. 
Thousands of pounds of Great Lakes fish have been condemned as unsafe because 
of PCB contamination, and New York State conservation officials warn against 
eating Hudson River fish. 

Water supplies throughout the Nation are contaminated far in excess of safe 
drinking criteria. 



236 



There has not been adequate monitoring of the extent of the pollution, nor of 
the sources of the pollution. 

At least 10 million pounds of PCBs are lost into the environment each year 
through vaporization, leaks, and spills, according to estimates reported by Thomas 
E. Kopp, a chemist with the EPA's Office of Toxic Substances. 

At least 10 plants are dumping PCBs into U.S. waterways and another two 
are discharging the chemicals in municipal sewage treatment systems, according 
to the EPA. 

PCBs have been banned for most uses in Japan — after the 1968 poisoning of 
more than 1,000 persons who had eaten PCB-tainted rice cooking oil. 

Alternatives have been instituted in Japan, and are being developed in the 
United States. For example, air-filled transformers have been used for years in- 
stead of PCB-filled transformers. 

Use of alternatives to PCBs may require retooling and redesigning of some 
electrical products and equipment which now use PCBs. 

PCBs are used in about 5% of all transformers and in almost all industrial 
capacitors in the United States. 

PCBs can be destroyed in special incinerators at very high temperatures. 

PCBs can be recycled. 

There is no dispute over their toxicity to wildlife and to humans. 

This amendment would allow time for the phasing out of the manu- 
facture and use of PCB's over years. 

It is preferable not to enact legislation on a substance-by-substance 
basis but rather generically, as the Toxic Substances bill proposes to 
do. However, the PCB problem shows no sign of abating and it has 
become so severe that it is necessary to address the problem head on, as 
we were forced to do with DDT. 

Mr. President, I ask unanimous consent to have printed in the Eec- 
ord three articles illustrating the extent of the problem and the com- 
mercial impact on the Great Lakes fishing industry as well as in New 
York State, as a result of PCB pollution in the Hudson River and 
Lake Ontario. 

There being no objection, the articles were ordered to be printed in 
the Record, as follows : 

[From Wisconsin Natural Resources, January/February 1976] 
Sources of Polychlorinated Biphenyls in Wisconsin 

Wisconsin's interest in PCBs began in the late 1960's when interfering sub- 
stances were detected in fish being tested for DDT. Later we were to learn these 
interfering substances were PCBs. 

In 1970, the Department collected fish samples along the Mississippi River 
bordering Wisconsin. Analysis revealed that between Prescott and Pepin fish 
commonly exceeded the Food and Drug Administration (FDA) tolerance level 
of 5 parts per million (ppm). During 1971, Lake Michigan fish were collected and 
later tested. Mean concentrations of PCBs in these fish ranged from 2.7 ppm in 
smelt to 15 ppm in lake trout. Subsequent studies confirmed the presence of 
PCBs in fish in Lake Michigan and other waters of Wisconsin. 

The search for PCBs in water was also underway at this time. An analysis of 
water from the Milwaukee River indicated that PCBs were present from West 
Bend to Lake Michigan and being discharged through municipal and industrial 
effluents. In 1971, eleven municipal wastewater treatment plant effluents in Wis- 
consin were sampled and nine contained PCBs. Studies of the Cedarburg waste- 
water treatment plant indicated that more than 70 percent of the PCBs coming 
into the plant were removed during the treatment process and comparatively 
high concentrations were found in the digester and primary settling sludges. 

The Department surveyed many municipal wastewater treatment plan effluents 
in Wisconsin from 1972 through 1974. PCBs were detected in concentrations ex- 
ceeding .05 parts per billion (ppb) in more than half of those tested even where 
there were no suspected industrial sources. In most cases, the discharge was well 
below 1 ppb and .01 ponds per day. However, higher concentrations were found 
in effluents from industrial areas. 



237 



Tracing sources of PCBs reaching a large municipal wastewater treatment 
plant is difficult and time consuming. The Department is attempting to trace 
sources of PCBs reaching treatment systems where the final effluent exceeds 1 
ppb. At present we know of only two municipal wastewater treatment plants in 
Wisconsin which exceed 1 ppb — Sheboygan and Portage. 

Main source of PCBs at Portage was found to be a facility that had used 
PCBs in the manufacture of carbonless copy papers prior to the summer of 1971. 
After ceasing the use and after repeated cleanings of holding tanks the dis- 
charge was substantially reduced. Residuals still remain, however, in the sewer 
system and the sewer sludges, resulting in an effluent of several ppb at the munici- 
pal sewage treatment plant. We are continuing to check sources of discharge at 
Sheboygan. 

The Department has checked effluents from iron and steel foundries and alu- 
minum foundries. Cooling water effluents from five of seven aluminum foundries 
contained PCBs ranging from 11.5 to 335 ppb. Close investigation revealed the 
common source to be leaking hydraulic fluids used in die cast machines. We are 
working with company officials to correct this. PCBs have been found in the cool- 
ing water effluent of only one of nine iron and steel foundries checked to date and 
that at a concentration of .9 ppb. 

DNR has tested effluents of 17 pulp and paper mills. Nine mills which recycle 
wastepapers had measurable discharges ranging from .1 to more than 25 ppb. 
Mill representatives indicate that the paper industry no longer uses PCBs and 
those found in wastepapers come primarily from carbonless copy papers which 
were produced prior to 1972. The old carbonless copy papers were widely used in 
forms and continue to enter the wastepaper market as old files are discarded. 
Because their solubility in water is low. we believe that most of the PCBs dis- 
charged from wastepaper mills are absorbed on fibers and other particulate mat- 
ter. Mill wastewater treatment systems which effectively remove particulate 
matter should also remove PCBs. 

The electoral industry continues to use PCBs as dielectric fluids in some ca- 
pacitors and transformers. Although the units are sealed some fluids may be lost 
as a result of accidents or disposal practices. In March 1975, the Department 
corresponded with major electrical companies in Wisconsin to determine cur- 
rent handling practices. This was followed by visits to many facilities. The com- 
panies contacted were aware of the problems, but some were not aware of recom- 
mended Guidelines of the American National Standards Institute for handling 
and disposal. We also found that some were storing defective capacitors until a 
proper disposal method could be found. As a result specific guidance was given 
to Wisconsin electric utilities for the proper handling and disposal. 

Snow samples were collected early in 1975 to determine if PCBs were deposited 
on land and water as fallout from the air. Analysis of snow melt water from 
Racine. Kenosha, Madison and Milwaukee revealed concentrations from .17 to .24 
ppb. These values suggest that fallout of PCBs from the air may be a principal 
source of PCBs entering the waters of the state. 

PCBs are present in sediments in harbors and streams near industrial areas. 
The sediments act as a reservoir from which PCBs may be released slowly over 
a long period of time. Sediment samples have tested 3.5 ppm in the Milwaukee 
River near the Capitol Drive Bridge, 9 ppm in Superior Harbor, and 72 ppm in 
the Fox River below the outfall of the Portage sewage treatment plant. 

We have tried to work out a materials balance for PCBs entering the environ- 
ment using the domestic sales figures provided by the Monsanto Company and 
other data. So many pieces are missing from the puzzle, however, that these 
efforts have been unsuccessful. However, some general comments can be made. 

1. PCBs have been sold by the Monsanto Company for more than 45 years. The 
company reported domestic sales of 795 million pounds from 1957 through 1974. 
In 1974 Monsanto's domestic sales were reported to be 34 million pounds for use 
in closed electrical systems. In addition, the Office of Toxic Substances EPA has 
reported that foreign sales of PCBs in the United States in 1974 exceeded 
375,000. 

2. The PCB problem in Wisconsin is a fishery problem caused because residues 
have accumulated in certain fish in Green Bay and Lake Michigan and the Upper 
Mississippi River in excess of the FDA tolerance level of 5 ppm. Laboratory ex- 
periments have shown that fish accumulate PCBs more than 100,000 times levels 
present in the water. Therefore, even parts per trillion (ppt) levels have signifi- 
cance to the fishery resource. 



238 



3. Our data indicates that levels of PCBs in fish in the Upper Mississippi River 
have declined in recent years. We have not detected a corresponding decline in 
levels in Lake Michigan fish. 

If Lake Michigan water contains an average of 10 ppt PCB then there are 
more than 100,000 pounds in solution and probably a much larger poundage in 
the sediments. We have tested the major effluents of both municipalities and in- 
dustries discharging to the Lake Michigan drainage in Wisconsin and estimate a 
discharge of about two pounds per day or 730 pounds of PCBs per year to Wis- 
consin's drainage to Lake Michigan. Most PCBs identified in our testing of 
major effluents occur in the wastewaters of pulp and paper mills which recycle 
wastepapers. 

Discharges of PCBs from pulp and paper mills, which recycle wastepapers, will 
diminish as the mills meet discharge permit requirements. Wisconsin mills 
which recycle wastepapers are required to reduce discharge of suspended solids 
from 131,000 pound per day (for calendar year 1973) to 45,000 pound per day 
by the 1977 compliance date. Recently one mill in the state, which uses only re- 
cycled paper, began a new treatment system that has reduced the discharge of 
suspended solids from 40,000 pounds per day to 3,000 pounds. Tests at this facility 
revealed 39 ppb PCB entering the treatment system with only 1 ppb being dis- 
charged in the final effluent. 

4. In our search for sources of PCBs entering the environment, we have not 
looked closely enough at fallout from the air. Our testing of snow melt suggests 
that fallout may be contributing much greater amounts of PCBs than are being 
contributed by industrial and municipal effluents. Trace concentrations in fallout 
over Lake Michigan and its watershed which cover 67,900 square miles could 
result in appreciable amounts entering Lake Michigan. 

Because PCBs are stable compounds with low vapor pressures, little loss is 
expected to occur through vaporization from disposal sites where capacitors 
and other equipment and materials have been disposed and covered with over- 
burden. Entry into the air may be expected to occur at locations where papers 
are incinerated, at foundries where imported casting waxes containing PCBs 
are heated to high temperatures and at manufacturing facilities. PCBs adsorbed 
on fine particulate matter may also be entering the air as windblown dust. 

5. Further information is needed to define the amount contributed to Lake 
Michigan and other waters through past accumulation in sediment. A University 
of Wisconsin study is currently underway in Southern Lake Michigan, which 
should proA'ide some answers. 

DNR does not have the authority to regulate the sale or use of PCBs, but can 
adopt affluent standards. 

In December the Natural Resources Board voted to severely limit PCB dis- 
charge. This action will be reviewed by the state legislature before it can become 
effective. The board also proposed legislation that would limit the sale and use 
of PCB's in Wisconsin. 



[From Bulletin of the Lake Michigan Federation, January-February 1976] 
PCBs Cost Jobs, Too 
(By Elizabeth Botts) 

Consumers aren't the only victims of PCB contamination in Great Lakes fish 
and waters. Fishermen had their livelihoods abruptly cut off when the Food and 
Drug Administration issued a ban on their contaminated produce last August. 
A group from Green Bay, Wisconsin, reported to the Federation that they plan 
to make their grievances publicly known. 

Mrs. James Hermes, of Green Bay, wrote to the Federation last October to 
ask for help in stopping the sources of PCB pollution in her area. "As long as 
little is done to stop the source, not merely the result," wrote Mrs. Hermes, 
"many more will suffer." 

But stopping the sources is a generous impulse that will help others, nor the 
Hermes family. "If PCB discharge is stopped, then how do we clean up the 
existing poison they have left with us?" she asked. "I'm sure the industries won't 
volunteer. They have gotten rich at everyone's expense but their own. 

Although there is growing concern in various government agencies on the effects 
of PCBs, the FDA is presently the only Federal agency with authority over 
their use, and can only ban contaminated wildlife that are harvested and proc- 



239 



essed for food consumption. That's why the Hermes' fisheries and other small 
fishing businesses like them were the only ones to suffer a federal injunction 
against their fishing activities. The sources of the Lakes' PCBs. e.g.. paper- 
recycling mills, are free from penalties. 

The Hermes are fourth-generation commercial fishermen. Ever since Jim 
Hermes' great-grandfather came to Wisconsin from Germany, before the turn of 
the century, the family has been sailing out of Green Bay. Xow there are two 
Hermes fisheries. Jane and Jim Hermes caught Lake Michigan carp and shipped 
them to Missouri as stock for private and municipal fishing ponds in and arouud 
St. Louis. Jim's cousin, Lee, and his wife. Glory, sold to canneries around Green 
Bay. Then, without warning, both groups were ordered to stop working. 

Not only could they not sell their fish, the St. Louis municipal authorities had 
to poison all sj^ecies of fish in the city's private and public fishing iK)nds to be 
sure of removing the Hermes carp. 

Lee Botts. then Federation Director, responded to Mrs. Hermes appeal, by ar- 
ranging for both Hermes families to attend the National Technical Conference on 
I'CBs organized by the EPA and other Federal agencies and held in Chicago 
last November. They told their story at the conference and on WGN-TV, pointing 
out that even if a ban were imposed immediately it would be years before PCB 
levels in fi.sh went down enough to permit harvesting. 

Things don't look good for the Hermes family. "We don't know what we're going 
to do," says Mrs. Hermes. "My husband and his cousin are going to try to work 
on some of the inland lakes where the PCB levels are low. but there aren't a lot 
of fish there. I don't know what will happen." Jane and Jim have four children 
and Lee and Glory have seven, so "it's quite a large family to lose their 
livelihood." 

The Hermes fisheries and others in the Green Bay area tried to get themselves 
declared a disaster area so they would qualify for Small Business Administra- 
tion loans, but the request was denied. 

The Wisconsin Department of Natural Resources doesn't have a lot of help 
for the Hermes either. According to Ron Poff. of the Great Lakes fishing section 
of the DNR. the Wisconsin Natural Resources Board had decided to call for stiff 
discharge limits and to draft legislation for a total ban on manufacture and 
sale of PCBs. but neither of these measures — if they are carried out — will be 
effective until 1977. There are powerful interests, including the Wisconsin Paper 
Council, who can be expected to oppose them. "Considering what paper means in 
Wisconsin," Poff says, "it's preitty substantial action. And it's the onlv action 
we c-an legally take." 

The only immediate help the DNR can offer to Green Bay fishermen is to look 
for areas where levels may be low enough to allow harvesting. Poff savs a few 
fisheries are already back at work on the Bay's far western edge. 

Still, it's probably too late for the Hermes, though Mrs. Hermes hasn't lost 
her anger or her determination. She's circulating a i)etition calling for a ban on 
PCB discharge, and hopes that this is one issue on which the sports and com- 
mercial fishermen of Lake Michigan can get together. 

The Hermes have retained a lawyer and are investigating the possibility of a 
lawsuit, but "there are so many dumping we wonldn't know where to start " 
And despite her hopelessness over her own situation, Mrs. Hermes still believes 
that something can be done about PCBs in Lake Michigan. 

"It's too late for us," she says now, "but maybe it won't be too late for some 
others. 



[From the American Medical News. Mar. S. 1976] 
PCB Discovery Leads to Fisn Bax 

Polychlorinated biphenyls (PCBs) from indus?trial pollution have contaminated 
fish HI the Hudson River and Lake Ontario. As a result. New York State has 
banned commercial fishing in the Hudson, and advised sportsfishermen to restrict 
their consumption of fish caught in these waters. The ban does not include shad ; 
analysis of these fish have shown low PCB levels. 

The FDA has set a ceiling of 5 parts per million (ppm) as the limit of PCB 
permissible in fish to be consumed by humans. PCBs cause an acne-like skin 
eruption, pigmentation of the skin and nails, excessive eve discharge, and 
swelling of the evelids. 



240 



FDA has found PCB levels as high as 31.3 ppm in fish caught in the Hudson 
and 24,6 ppm for salmon from Lake Ontario. 

Mr. TuNNEY. Mr. President, I have had the opportunity to look at 
this amendment. It was submitted by the Senator from Wisconsin 
yesterday. I commend him in his efforts to control the hazards asso- 
ciated with the PCB's. We know how dangerous they can be. 

I think the Senator's amendment strengthens the legislation and I 
am prepared to accept it for both minority and majority on the Com- 
merce Committee. 

Mr. President, I commend the distinguished Senator from Wiscon- 
sin on his efforts to control the hazards associated with PCB's. PCB's 
have long been of concern to the Committee on Commerce as evidenced 
by hearings held on the subject by the Subcommittee on the Environ- 
ment last October 24. 

Those hearings documented the fact that despite assurances from the 
sole domestic manufacturer of PCB's, they are still escaping into the 
environment in awesome quantities, in fact some 10 million pounds per 
year. Although an agreement several years ago by the Monsanto Co. 
supposedly retricted PCB's use to closed systems, ^Monsanto obviously 
has no control over those to whom it sells PCB's nor does Monsanto 
have any control over those who import PCB's. Thus, PCB's are still 
being used for nonclosed system uses. 

At the same time, PCB's have been shoAvn to cause cancer in one 
study, and to interfere with reproduction. 

In my view, the amendment of the Senator from Wisconsin is indeed 
appropriate. It phases PCB's out by eliminating nonclosed system uses 
within 1 year and eliminating PCB's altogether within 2 years. There 
are mechanisms for authorizing uses of PCB's beyond these time limits 
should that be appropriate so that we do not create worse problems 
than those we solve. 

In my view, the amendment is a fine addition to the bill, and I urge 
its adoption. 

The Presidixg Officer. The question is on agreeing to the amend- 
ment of the Senator from Wisconsin. 
The agreement was agreed to. 

Mr. Canxox. Mr. President, I send an amendment to the desk and 
ask for its immediate consideration. 

The Presiding Officer. The amendment will be stated. 
The second assistant legislative clerk read as follows : 

The Senator from Nevada (Mr. Cannon) proposes an amendment : 
On page 36, line 17, [Sec. 6(a)(1)], insert the following: 

After the word "risk,"' insert a comma and the words "using the least burden- 
some effective controls." 

Mr. Canxox. Mr. President, I ask unanimous consent that Senator 
Johnston be included as a cosponsor. 

The Presidixg Officer. Without objection, it is so ordered. 

Mr. Caxxox. Mr. President, this is simply a clarifving amendment 
to be sure that the administrator does use the least burdensome effec- 
tive procedure. I hope the Senator will be willing to accept it. 

Mr. Beall. Mr. President, I rise to support S. 3149, the Toxic Sub- 
stances Control Act, and hope that the Senate will oive its overwhelm- 
ing endorsement to this measure. 



241 



Twice before, in 1972 and 1973, the Senate passed toxic substances 
legislation, only to be frustrated in our efforts to reach acrreenient with 
the House of Representatives on this matter. This year, however, indi- 
cations are that chances for Senate-House agreement are good, and 
thus we will be able to place a strong toxic substances bill on the Presi- 
dent s desk prior to adjournment of the 94tli Congress. 

I can think of no more pereuasive argument in favor of this legisla- 
tion than the stories which have appeared almost daily in the press 
regarding the serious chemical hazards now present in our environ- 
ment. In recent months, we in this country have become painfully 
aware of the catastrophic long-term effects that such chemicals as ke- 
pone, vinyl chloride, mercury, and PCB's may have on humans. In 
fact, approximately 1,000 new chemicals are marketed each year, to 
find their way into' our environment. These chemicals need to be pre- 
tested before' they enter the market, and this bill accomplishes that 
purpose in a reasonable and responsible manner. 

The committee has also made great efforts in this legislation to bal- 
ance the health needs of our people with economic realities. Through- 
out the bill, the Administrator of the Environmental Piotection 
Agency is required to fully consider the reasonably ascertainable eco- 
nomic effects of his actions and publish them for the public record. 

Mr. President, the terrible effects of toxic chemicals are often not 
evident until many years after initial exposure. Russell Train, Admin- 
istrator of the EPA, recently pointeii out that Americans were, with- 
out either their knowledge or consent, often engaging in a grim game 
of chemical roulette. This legislation seeks to end that game, which 
can have no winners, and I urge the Senate to give its strong support 
to this much-needed and long-awaited legislation. 

Mr. TrxxEY. Mr. President, I have had an opportunity to review 
the amendment that is being offered by the Senator from ?s^evada and 
I would like to ask him a question with respect to it. 

If the Senator's amendment is agreed to and is made a part of the 
law, unreasonable risks must still be prevented and protected against, 
must they not? 

Mr. Caxnox. Is the Senator talking about the amendment we just 
acted upon or the other amendment we are considering ? 

Mr. TuNNEY. I am talking about the amendment the Senator offered, 
aft^r the word ''risk," insert a comma and the words "using the least 
burdensome of effective controls.'' 

The Presidixg Officer. The Chair advises the Senator, that is the 
pending amendment, it is now pending. 

Mr. Caxxon. Yes; the answer to the Senator's question is ''Yes." 

Mr. TuNXXY. Fine. 

Then under those circumstances. I do not see any reason at all that 
this amendment should not be accepted. I feel that as long as it is very 
clear in the Record that unreasonable risks must still be prevented 
under the regulatory framework, certainly it would be important to 
use the least burdensome of effective controls to effectuate that desired 
result. 

So I accept the amendment. 

Mr. Pearsox'. Mr. President, it is my understanding the effective 
control is still the essentiality of what the Administrator will do. 



242 



Mr. Cannon. Yes. 

Mr. Pearson. And this amendment just seeks the least burdensome 
procedure to get there ? 

Mr. Cannon. The Senator is correct. 
Mr. Pearson. I find it acceptable. 

Mr. Cannon. We do not want to give the Administrator unlimited 
authority and let him say, "I will impose this control," if there are 
other controls that are effective and are less burdensome on the 
industry. 

That is really what is intended. 

The Presiding Officer. The question is on agreeing to the 
amendment. 

The amendment was agreed to. 

Mr. Cannon. Mr. President, I send an amendment to the desk and 
ask for its immediate consideration. 

The Presiding Officer. The amendment will be stated. 
The second assistant legislative clerk read as follows : 

The Senator from Nevada (Mr. Cannon) for himself, Senator Laxalt, and 
Senator Johnston proposes an amendment : 

On page 5, line 2, [Sec. 6(d)(2)] after "(3) insert "in those situations where 
compliance with the requirements of subsection (c) (2) or (3) would present 
an unreasonable risk of death, serious or substantial personal injury (including 
illness) or serious or substantial environmental harm." 

Mr. Cannon. Mr. President, in the Commerce Committee several 
members expressed concern that a provision in the bill authorizing 
the Administrator to make rules regulating chemical substances im- 
mediately effective was too broad. Efforts Avere made to narrow that 
authority to those situations Avhere the public interest required, and an 
existing provision in the Administrative Procedure Act was referenced. 

Unfortunately, the language in the APA is somewhat ambiguous and 
could be interpreted to permit the EPA Administrator to waive the 
due process requirements of the rulemaking provisions at whim. That 
certainly was not the intent. 

Therefore, this amendment that is submitted is perfecting the 
language of section 6(d)(2) of the bill. 

The perfecting language prohibits the Administrator from waiving 
the due process requirements of section 6 rulemaking unless compli- 
ance would present an unreasonable risk of serious or substantial in- 
jury to health or the environment. This limits the authority to put 
rules into effect quickly to those cases where there is real need to pro- 
tect the public health or environment immediately and I think car- 
ries out better the intent of the Committee and particularly my intent 
in offering the original amendment in committee. 

I Avould hope that the amendment Avould be agreed to, Mr. 
President. 

Mr. Hartke. Mr. President, let me say about the amendment sub- 
mitted by the Senator from Nevada that I think this amendment should 
be satisfactory to the committee and also to the manager of the bill. 
This Avas the heart of a lot of discussion in the Senate Commerce Com- 
mittee. I think the Senator from Nevada has correctly stated the situa- 
tion. We want to make sure that the Administrator has the authority ; 
we want to make sure that due process is protected ; we Avant to make 
sure that there is not an unreasonable delay in absolute prohibition in 
case it needs to be done. 



243 



On the other side of the coin we wanted to make sure there was not 
some type of arbitrar}^ decision by the Administrator. I believe the 
amendment by the Senator from Nevada does carry out the intent of 
the committee at the time. We had long discussions about this matter. 
I do thing possibly it could be misinterpreted or be ambiguous in the 
way it was originally drafted. 

Mr. TuxxEY. I want to thank my friend from Indiana for that ex- 
planation. I am impressed by his comments, and by what the Senator 
from Nevada said. 

I would like to ask the Senator from Nevada a question. What is 
meant by serious and substantial personal injury as it is contained 
here, or serious or substantial environmental haiTQ ? 

Mr. Cannon. A ''serious'* illness would be one causing a high degree 
of illness to a relatively small number of people whereas a substantial 
illness would be one involving a lesser degree of illness but affecting a 
large portion of the population. 

Mr. TuNNEY. I have no objections to the amendment and I am pre- 
pared to accept it. I am authorized to accept it for the minority. 

The Presiding Officer. The question is on agreeing to the 
amendment. 

The amendment was agreed to. 

The bill is open to further amendment. If there be no further amend- 
ment to be proposed, the question is on the engrossment and third 
reading of the bill. 

The bill was ordered to be engrossed for a third reading and was 
read the third time. 

Mr. Thurmond. Mr. President, I have received numerous letters 
from companies operating in my State, and some out of the State, 
concerning this bill. 

I would like to call to the attention of the Senate a few of these 
letters. 

Certainly, I w^ant to take every step possible to protect our people, 
but it appears that this bill goes further than necessary. 

I have a letter in my hand from ^filliken Chemicals, which I would 
like to read into the Record. 

The Toxic Substances Control Act is probably the most serious threat the chem- 
ical industry has ever faced. This bill could require that before any chemical is 
sold, even in research quantities, it be subjected to all the tests required of a new 
drug. 

The tests that could be required would easily cost $100,000 and. in many cases 
much more. The authority to determine just how many tests and what tests would 
be run will reside with the administrator of the EPA. While it is possible that a 
reasonable administrator would not be too severe, it is undesirable to have the 
welfare of one's business hang on the whim of an administrator. Furthermore, 
according to the bill, any person may initiate a civil action for injunctive relief. 
Therefore, any manufacturer is not only at the mercy of the administrator but is 
also at the mercy of any citizen who has an "axe to grind". 

Five reasons for you to oppose this bad piece of legislation : 

1. It is unnecessary : We already have 27 health and environmental laws which 
cover the "toxic chemicals" that this bill would regulate. 

2. It will be inflationary : It will increase the cost of production because of the 
severe testing required. It will reduce the number of products available and re- 
quire the use of more expensive products in many cases. 

3. It will stifle progress : Unnecessary restrictions will seriously hamper the 
flow of new products and we will be frozen into products we now have — some of 
which products have serious limitations and which could be improved if research 
and development were allowed to continue with reasonable caution. 



244 



4. It will drive industry overseas : Many companies will be forced to take their 
research and production to other countries where laws are less oppressive. 

5. It is vague. The bill gives an EPA Administrator very broad authority with 
very few restrictions. 

6. It probably won't work. Even one who supports the bill admits, "this bill 
will not, of course, catch all of the dangers. Some of the adverse effects occur in 
such unique circumstances or after very long times (up to 20 years in some 
cases) that it would be extremely diflBcult to diagnose their dangers. Very long- 
term testing would be very costly to industry and would seriously delay use of 
some valuable new chemicals." The logic here is inescapable. 

This bill will have a serious effect throughout industry. Even those who use 
specialty chemicals or buy products that require specialty chemicals in their 
manufacture will have problems. 

The large companies may be able to meet the excessive costs and red tape in- 
volved but it is bound to increase their costs. It is questionable if the small com- 
pany can survive. 

I appeal to you to seriously consider the reasons outlined in this letter and 
put the face of your oflSce behind the effort to defeat this proposed legislation. 
Sincerely, 

C. M. Butler, 
General Manager. 

Mr. President, I have another letter here from a smaller company, 
the Graniteville Co. in Graniteville, S.C. It reads: 

Dear Senator Thurmond : I am writing you about my deep concern over the 
Toxic Substances Control Bill that is presently in the final draft stage of the 
Senate and House Subcommittees. It is quite evident that if the Tunney Bill is 
passed in its present form, many chemical companies, both large and small, could 
possibly be out of business in short order. The textile industry has had to wrestle 
with many new government regulations in the last few years, many of which have 
been most beneficial, while others have taxed the sanity of most corporate 
management. 

As I am sure you are aware, Graniteville Company has had a small wholly- 
owned subsidiary which manufactures dyes and chemicals. This Bill would re- 
quire a ninety-day notice for manufacture or import of new chemicals, a ninety- 
day notice on change in formulations or on new uses of existing chemicals, and 
has broad powers to stop the manufacture of any chemical or finished product. 
In addition, the cost of testing each new chemical would approximate $100,000 to 
$300,000 and would increase the operating costs of our subsidiary by millions of 
dollars if this law were strictly enforced. I strongly believe that almost every 
business has worked closely with and survived OSHA, EPA and other govern- 
ment agencies, but we cannot survive if this Bill is passed and enforced in its 
present form. 

Mr. President, those letters are typical of others I have received, and 
I ask unanimous consent that a number of additional letters be printed 
in the Record following these. 

There being no objection, the letters were ordered to be printed in 
the Record, as follows : 

Monsanto Textiles Co., 
Greenwood, S.C, J,anuary 19, 1976. 

Hon. Strom Thurmond, 
U.S. Senate, 
Washington, D.C. 

Dear Senator Thurmond : As manager of Monsanto's plant in Greenwood, I 
want to express my strong opposition to the all-encompassing nature of toxic 
substances legislation currently being considered by committees in the Congress. 
The bills could seriously impact 2100 people, engaged in the manufacture of 
nylon at our Greenwood location, plus another 278 Monsanto employes working 
elsewhere in South Carolina. 

I do support appropriate legislation on toxic substances for the pubhc's wel- 
fare, but the pending bills (S. 3149 and H.R. 10318) are overly burdensome to 
industry and detrimental to the public interest. It seems to me that this is an- 
other example of the overregulation which concerns us all today. 

Specifically, the bills could impose costly and unnecessary testing requirements, 
on new and existing chemical substances without regard to the risk which may 
be involved. They also require regulations on the manufacture and use of sub- 



245 



stances, based on the mere possibility of an unreasonable risk, without requiring 
an economic impact statement, even though the rules could ban production, shut 
down plants, and terminate jobs. Uncertainty in enforcement would occur since 
duplicative actions by different Federal agencies are encountered. 

These defects can be corrected. A bill which meets many of these concerns has 
been introduced by Rep. John McCollister, H.R. 7664). I urge you to actively sup- 
port legislaticni like the McCollister bill, and work against bills which threaten 
entire industries and payrolls with needless over-regulation. I hope you will also 
voice your concern to committee members now considering toxic substances bill. 

Congratulations on again becoming a proud father. I know Nancy got first 
class treatment at the hospital here and your son was very photogenic ! 
Sincerely, 

R. T. Phelps, Jr., 

Plant Manager. 



Exxon Chemical Co., U.S.A., 
Summerville, 8.C., January 22, 1976. 

Hon. Strom Thurmond, 

U.S. Senate, Senate Office Building, Washington, D.C. 

Dear Senator Thurmond : As a follow-up to my telephone call of today to Mr. 
John Steer, I would like to set forth in somewhat more detail my company's 
concerns regarding the Toxic Substances Control Legislation (S. 3149) (H.R. 
10318) now before the Senate (House). 

We support appropriate legislation in this area but are convinced that this bill, 
if enacted, would be overly burdensome (particularly to the small companies 
which compri.se the bulk of the chemical industry), would unnecessarily increase 
costs, would stiffle innovation and, ultimately, would make the U.S. chemical 
industry much less competitive than its strong counterparts in Europe and 
Japan. 

This legislation could impose costly and unnecessary testing requirements 
with resi)ect to new and existing chemical substances, in many cases without re- 
gard to tlie relative level of risk which may be involved. It requires the promul- 
gation of rules governing the production and use of chemical substances on the 
mere i)Os.sibility that these substances may present an unreasonable risk. It 
doesn't even require the preparation of an economic impact statement although 
the regulations could l>an the production of a chemical, shut down the plants 
making it or using it, and terminate the jobs involved. The bill would also create 
uncertainty in the enforcement of Federal laws by encouraging duplicative ac- 
tion by different Federal agencies and would permit the EPA to pick and choo.se 
among potentially applicable laws. 

My company believes that a law as broadly drawn as this would be, giving 
vast powers to the Administrator of the EPA without his being required to con- 
sider and weigh the economic con.sequences of his actions, is neither necessary 
nor appropriate to control toxic substances. In our view, appropriate legislation 
is exemplified by H.R. 7664, which has been introduced in the current Congress 
by Rep. John McCollister. It is similar to a bill passed by the Hou.se in the last 
Congress and provides adequate means of controlling toxic .substances without 
needless and costly overregulation. I hope you will support this kind of legislation 
rather than S. 3149 (H.R. 10318) which could result in such adverse conse- 
quences to industry without offering added assurance of public safety. 

I am attaching a summary of some of the major concerns of the chemical in- 
dustry regarding the bills now before Congressional committees, as compiled by 
the Manufacturing Chemists A.ssociation. If you wish additional information, 
I'll be happy to provide it. 
Sincerely yours, 

J. J. Jamison. 



Firestone Steel Products Co., 
Spartanburg, S.C., January 19, 1976. 

Hon. J. Strom Thurmond, 
U.S. Senate, 
Washington, D.C. 

Dear Senator Thurmond : Despite the firm commitment of The Firestone Tire 
& Rubber Company to the prevention of undue risk to human health and the envir- 
onment at its manufacturing plants, I am deeply concerned about certain provi- 



246 



sions of the toxic substances control bills currently before the Committees of the 

^""ourcompany supports appropriate legislation in this area, but the pending 
bills (S. 3149 and H.R. 10318) are unduly burdensome to industry and could be 
detrimental to the public interest for the following reasons : , . , , 

1 By imposition of costly and unnecessary testing requirements with respect to 
new and existing chemical substances, in many cases without regard to the rela- 
tive level of risks which may be involved ; , ^. ^ 

2 By requiring the promulgation of rules governing the production and use ot 
chemical substances on the mere possibility that these substances may present an 
unreasonable risk, without recourse to an economic impact statement ; 

3 By creating uncertainty and duplication of Federal law enforcement under a 
plan which permits the EPA to pick and choose among potentially applicable 
statutes. . , . , ^ „ , , 

These are all correctible defects. In fact legislation which met many of these 
concerns passed the House of Representatives in the last Congress. A similar bill, 
H.R. 7664, has been introduced in the current Congress by Rep. John McCollister. 
I urge Members of Congress to actively support legislation like the Mc(.V)llister 
bill, H.R. 7664, and to work against the enactment of legislation which would 
threaten entire industries with needless regulation without offering added assur- 
ance of public safety. 

I hope you will also voice your concern to members of the committee now con- 
sidering toxic substances control bills. 
Sincerely, 

D. E. Oldham, 
Plant Manager. 



W. R. Grace & Co., 

ZONOLITE, 

Enoree, S.C., January 19, 1916. 

Hon. Strom Thurmond, 
U.S. Senate, 
Washington, D.C. 

Dear Sir : As Manager of W. R. Grace & Co.'s Kearney Plant at Enoree, South 
Carolina, I wish to express to you my views concerning some bills now before the 
Congress. 

Our plant produces vermiculite, and at present employs approximately 115 men 
and women. 

Despite the firm commitment of the chemical industry to the prevention of un- 
due risk to human health and the environment from exposure to toxic chemicals, 
we are deeply disturbed and concerned about the provisions of the toxic sub- 
stances control bills currently under consideration by the Committees of the 
Congress. 

We support appropriate legislation in this area, but the pending bills (S. 3149 
and H.R. 10318) are overly burdensome to industry and detrimental to the public 
interest. They could impose costly and unnecessary testing requirements with re- 
spect to new and existing chemical substances, in many cases without regard to 
the relative level of risk which may be involved. They require the promulgation 
of rules governing the production and use of chemical substances on the mere 
possibility that these substances may present an unreasonable risk, and do not 
even require the preparation of an economic impact statement, although the regu- 
lations could ban the production of a chemical, shut down the plants making it or 
using it, and terminate the jobs involved. The bills would also create uncertainty 
in the enforcement of Federal laws by encouraging duplicative action by different 
Federal agencies and would permit the EPA to pick and choose among potentially 
applicable laws. 

These are correctible defects. In fact, legislation which met many of these 
concerns passed the House of Representatives in the last Congress. A similar 
bill, H.R. 7664, has been introduced in the current Congress by Re.p. John 
McCollister. We urge Members of Congress to actively support legislation like 
the McCollister bill, H.R. 7664, and to work against the enactment of legislation 
which would threaten entire industries with needless regulation without offering 
added assurance of public safety. 



247 



I hope you will also voice your concern to Members of the Committee now 
considering toxic substances control bills. 
May I count on your help? 
Yours very truly, 

O. F. Stewabt, 

Manager. 

Fiber Industries, Inc., 

January 19, 1976. 

Hon. J. Strom Thurmond, 
Dirk sen Senate Office Building, 
Washington, D.C. 

Dear Senator Thurmond : As the Plant Manager of the Greenville Plant of 
Fiber Industries, Inc., situated in Greenville, S.C.. I wish to follow up the con- 
versation between Hugh RoUinson, Technical Manager and Mr. John Steer, in 
expressing our opposition to S. 3149, the Toxic Substances Control Bill, in its 
present form. This measure is now before the Senate Commerce Committee. 

S. 3149 requires premarket testing and screening. I'm not opposed to this broad 
concept. As one well versed in the chemical industry I have consistently sup- 
ported legislation that would require reasonable testing and premarket screening 
of chemical substances which are likely to pose a "substantiar' danger to health 
and the environment. By "substantial" danger, I mean unreasonable risk of death 
or severe i)ersonal injury or illness as well as widespread or severe harm to the 
environment. 

I am opposed to S. 3149 because I believe it would retard basic research, 
the development of new products and the development of new uses for existing 
products by requiring excessive and routine long term testing and premarket 
screening requirements for individual chemical substances or classes or such 
substances. 

S. 3149 requires all new substances which "may present'' [Sec 4(a) (1) (A) (i)] 
an unreasonable risk to public health be tested and screened in accordance with 
E.P.A. procedures. I have earned over the year sthat testing for chronic effects 
to determine the carcinogenic ix)tential of materials is long term taking two to 
four years to complete with costs from $300-$750.000. 

I'm not in favor of trade-off testing at the expense of safety but I do believe 
that unnecessary tes*ting and screening is not only wasteful of the valuable 
time of a limited number of highly qualified technicians we have in our company 
but wasteful of financial resources, for these activities neither contribute to 
protecting health or the environment and impede research and development. 

The term "unreasonable risk" used throughout the bill and in my judgment 
is too broad and needs to be strictly defined in a meaningful way as I suggested 
earlier. With such a guide or standard, testing and screening would be limited to 
those products presenting significant risks and the likelihood of excessive and 
unreasonable testing would be minimized. In the same vein, it seems to me that 
the language ''may present'' should be changed to "present" to require action 
based upon fact rather than a mere possibility of fact. 

I believe that toxic substances legislation should be limited to gap areas not 
covered by other laws. It seems to me that S. 8149 goes far beyond the gap areas 
and overlap laws such as the Clean Air Act and the Water Act. I feel this legisla- 
tion should be operative only when a risk to health and the environment cannot 
be suflSciently presented or reduceti by other Federal laws. 

An Amendment has been offered to S. 3149. The Amendment No. 21 would 
permit the granting of equitable relief where there is a risk to human health 
without requiring proof by the plaintiff rather the burden of proof would be 
shifted to the defendant to demonstrate that no harm to human health exists. 
This seems to me to be an impossible legal and scientific burden and should be 
eliminated. 

Any added costs from unnecessary and impractical testing requirements will 
be felt throughout the host of vital consumer related industries dependent upon 
the chemical industry for their essential raw materials. Therefore, I believe that 
Section 6 of S. 3149, the section which provides authority to restrict or limit 
manufacturing and sales, should have language added to it to the effect that 



248 



when regulations and other major actions are initiated under the proi>osed act 
that they are evaluated for their impact upon jobs and upon the economy. 

I would welcome the opportunity to speak with you or Mr. John Steer further 
on this matter at your convenience. Please do not hestitate to call me if I can be 
of any help in this matter. 
Yours sincerely, 

Burton E. Cash, 

Plant Manager. 



E. I. DU Pont de Nemours & Company, 

Flcyrence, S.C., January 19, 1976. 

Re Toxic Substances Control Lregislation. 
Hon. J. Strom Thurmond, 
U.S. Senate, 

Dirkscti Office BuiMing, 
Washington, B.C. 

Dear Strom : You will recall from your visits to our plant that we employ 650 
people at this location. Our product is "MYLAR" ^ a tough plastic film used by 
the following industries : magnetic tape, electrical insulation, packaging, micro- 
film, engineering drawings, and laminating. Our new Plant Manager is Dr. R. D. 
Pruett and lam writing you at his request. 

Despite the firm commitment of the chemical industry to the prevention of 
undue risk to human health and the environment from exposure to toxic chemi- 
cals, we are deeply disturbed and concerned about the provisions of the toxic 
substances control bills currently under consideration by the Committees of the 
Congress. 

We support appropriate legislation in this area, but the pending bills ( S. 3149 
and H.R. 10318) are overly burdensome to industry and detrimental to the public 
interest. They would impose costly and unnecessary testing requirements with 
respect to new and existing chemical substances, in many cases without regard 
to the relative level of risk which may be involved. They require the promulgation 
of rules governing the production and use of chemical substances on the mere 
possibility that these substances may present an unreasonable risk, and do not 
even require the preparation of an economic impact statement although the 
regulations could ban the production of a chemical, shut down the plants making 
it or using it. and terminate the jobs involved. The bills would also create uncer- 
tainty in the enforcement of Federal laws by encouraging duplicative action by 
different Federal agencies and would permit the EPA to pick and choose among 
potentially applicable laws. 

These are correctible defects. In fact, legislation which met many of these 
concerns passeil the House of Representatives in the last Congress. A similar 
bill, H.R, 7664, has been introduced in the current Congress by Rept. John Mc- 
Collister. We urge Members of Congress to actively support legislation like the 
McCollister bill, H.R. 7664. and to work against the enactment of legislation which 
would threaten entire industries with needless regulation without offering added 
assurance of public safety. 

I hope you will also voice your concern to Members of the Committee now 
considering toxic substances control bills. Should you want more details on our 
concerns. I will supply it. 

We know that we can always depend on you to take a realistic position on such 
issues. 

Sincerely, 

R. D. Pruett, 

Plant Manager. 
Per: M. B. Wallace, Jr., 
Employee Relations Superinteyident. 



1 Reg. U.S. Patent Office for rhi Pon't polyester film. 



249 



Fiber Industries, Inc., 

January 19, 1976. 
Hon. J. Strom Thurmond, ^ 
U.S. Senate Office Building, 
Washi7ifftoti, D.C. 

Dear Senator Thurmond : I am writing to you as Plant Manager of Fiber 
Industries Palmetto Plant located in Darlington County concerning certain op- 
position to S. 3149 (Toxic Substances Control Bill) which is now before the 
Senate Commerce Committee. 

I am certainly in favor of sound legislation for control of toxic substances to 
the greatest extent possible through existing regulatory agencies. S. 3140 in its 
present form would, however, encourage duplication and uncertainty with respect 
to laws administered by the administrator. 

The term "unreasonable risk" is used throughout the bill and seems to me to 
be too broad which, along with the term "may present," will very probably 
result in unnecessarily, costly and progress-stifling requirements for testing 
and screening. 

Any added costs from unnecessary testing requirements will be felt throughout 
the vital consumer-related industries such as ourselves which dei^end on the 
chemical industry for their raw materials. I believe, therefore, that Section 
should have hinguage to the effect that when regulations and other major actions 
are initiated they be evaluated for their impact on jobs and upon the economy 
as well as health risk. 

In summary, I hope that correctable general and vague language will be changed 
so that unreasonable burdens are not placed where unreasonable risks do not 
in fact pose substantial danger. 
Yours truly, 

E. J. Scott, Plant Manager. 



Anderson, S.C, Mareh 15, 1916. 

U.S. Senator Strom Thurmond, 
Senate Office Building, 
Washington, D.C. 

Dear Senator Thurmond : I am greatly concerned over the phenomenal growth 
of reguhitions and regulatory agencies. It api)ears that Congress and the Presi- 
dent have only one approach to solving our problems as a nation and that is to 
create more regulations and agencies to administer these. What we need today 
is less rather than more governmental regulation of our business and individual 
hves. 

As a typical citizen, it is obvious to me that Congress has put little thought 
into the total ramifications and consetpiences of a given regulation or set of 
regulations. In most cases an exi>ensive. inefficient, bungling fedeal agency is 
created. Further the citizen and business in the U.S. must bear the brunt of more 
red tape. And in terms of business, many regulations will be indirectlv respon- 
sible for the slow death of capitalism. 

Specifically I am opix)sed to the propo.sed toxic substances legislation presently 
before Congress. There are already in excess of 25 healtli and environmental laws 
presently in effect. These laws give the federal government adequate authority 
to contol dangerous substances. 

The Environmental Protection Agency would be given near absolute control of 
the cheniical industry. In effect making the administrator of this group a dicta- 
tor over the chemical industry. 

This legislation would have an inflationary impact through increased cost of 
goods to the consumer. It would also reduce the discovery of new chemical pro- 
ducts. And finally, it would reduce the number of jobs available. 

As one of you constituents. I would appeciate knowing vou position on this 
proposed legislation and if you believe it will became law. Thank you for your 
kind indulgence. 

Respectfully, 

Dr. Herbert L. Whitaker, .Jr. 



79-313 O - 77 - 17 



250 



Whitestone Chemical, a Department of BASF Wyandotte Corp., 

Spartanburg, S.C., January 19, 1976. 

Hon. Strom Thurmond, 
U.S. Senator, Aiken, S.C. 

Dear Senator Thurmond : Whitestone Chemical, a Department of BASF- 
Wyandotte Corporation, is a manufacturer of specialty chemicals for the textile, 
paper, leather and other industries here in Spartanburg. Current employment is 
forty-one with an annual payroll of approximately $500,000. Whitestone is a sig- 
nificant contributor to the economic well-being of the Spartanburg area. 

My company is firmly committed to the prevention of undue risk to human 
health and the environment from exposure to toxic chemicals. We are, however, 
deeply disturbed and concerned about the provisions of certain toxic substances 
control legislation, S. 3149 and H.R. 10318, currently under consideration by the 
Senate Commerce Committee and the House Interstate and Foreign Commerce 
Committee. 

Review of the controls now in existence on toxic substances does convince us 
that some additional legislation is appropriate. However, S. 3149 and H.R. 10318 
represent, in our opinion, legislative overkill. We believe they go far beyond what 
is required to provide reasonable protection to chemical workers, consumers and 
the general public and would burden all of these groups with costly and unneces- 
sary testing equirements with respect to existing and new chemical substances. 
These bills lack standards for exercising good judgment as to the relative level 
of risk that may be involved ; rather, they would condemn all chemicals without 
regard to historic data, the relative level of risk that may be involved or the 
economic impact that would result. Appropriate legislation must provide for 
taking the economic impact into account because the cost of complying with the 
legislation will fall on consumers and the general public and our country in total. 

As stated previously, we do believe, that some further legislation is required 
and H.P. 7664 introduced into the current Congress by Representative John 
McCollister would accomplish what we believe is needed. H.R. 7664 would provide 
necessary protection at reasonable cost. We urge you to support actively the 
McCollister bill and to oppose S. 3149 and H.R 10318. 

Even though Whitestone is a department of BASF- Wyandotte Corporation, we 
operate as a separate company and therefore must pay our own way. The eco- 
nomic impact associated with the toxic substances control bills could be ex- 
tremely detrimental to the continued operation of Whitestone, and many other 
small chemical companies in South Carolina. 

If you share our concerns, we hope that you will voice them to the members of 
the Senate Committee now considering toxic substances control bills. We would 
appreciate learning your position on this legislation. 
Sincerely. 

T. W. Beal, Plant Manager. 



E. I. DU Pont de Nemot'rs & Co.. 
Florence, S.C, January 10, 1976. 

Re Toxic Substances Control Legislation. 
Hon. J. Strom Thurmond, 
U.S. Senate, Dirkscn Office Building, 
Washington, B.C. 

Dear Strom : You will recall from your visits to our plant that we employ 650 
people at this location. Our product is "MYLAR"*, a tough plastic film used by the 
following industries : magnetic tape, electrical insulation, packaging, microfilm, 
engineering drawings, and laminating. Our new Plant Manager is Dr. R. D. 
Pruett and I am writing you at his request. 

Despite the firm commitment of the chemical industry to the prevention of 
undue risk to human health and the environment from exposure to toxic chemi- 
cals, we are deeply disturbed and concerned about the provisions of the toxic 
substances control bills currently under consideration by the Committees of the 
Congress. 

We support appropriate legislation in this area, but the i)ending bills ( S. 3149 
and H.R. 10318) are overly burdensome to industry and detrimental to the public 
interest. They could impose costly and unnecessary testing requirements with re- 
spect to new and existing chemical substances, in many cases without regard to 
the relative level of risk which may be involved. They require the promulgation 



251 



of rules governing the production and use of chemical substances on the mere pos- 
sibility that these substances may present an unreasonable risk, and do not even 
require the preparation of an economic impact statement although the regula- 
tions could ban the production of a chemical, shut down the plants making it or 
using it, and terminate the jobs involved. The bill would also create uncertainty 
in the enforcement of Federal laws by encouraging duplicative action by differ- 
ent Federal agencies and would permit the EPA to pick and choose among poten- 
tially applicable laws. 

These are correctible defects. In fact, legislation which met many of these con- 
cerns passed the House of Representatives in the last Congress, A similar bill, 
H.R. 7664, has been introduced in the current Congress by Rep. John McCollister. 
We urge Members of Congress to actively support legislation like the McCollister 
bill, H.R. 7664, and to work against the enactment of legislation which would 
threaten entire industries with needless regulation without offering added assur- 
ance of public safety. 

I hope you will also voice your concern to Members of the Committee now con- 
sidering toxic substances control bills. Should you want more details on our con- 
cerns, I will supply it. 

We know that we can always depend on you to take a realistic position on such 
issues. 

Sincerely, 

R. D. Pruett. 

Plant Manager. 
Per: M. B. Wallace, Jr., 
2'Jmployee Relations Superintendent. 



Ashland Chemical Co., 
DiviMon of Ashland Oil, Inc., 
Charlotte, N.C., February 2, 1976. 

Hon. Strom Thurmond, 
U.S. Senate, 

Dirkscn Senate Office Building, Washington, D.C. 

Dear Senator Thurmond : As regional manager of the Industrial Chemicals 
»& Solvents Division of Ashland Chemical Company stationed in Charlotte, N.C., I 
am very much concerned about the so-called Toxic Substance Control measures, 
which are currently under consideration by the Committees of the Congress. In- 
cluded under my jurisdiction are the two Carolinas; and the havoc that would 
be raised, not only in this area but industry-wide if the bills in question should 
be enacted into law, would be monumental. Once again, therefore, I am seeking 
your assistance. 

Despite the firm commitment of the chemical industry to the prevention of 
undue risk to human health and the environment from exposure to toxic chemi- 
cals — and we support legislation in this area — the provisions of the pending 
measures, Senate bill 3149, introduced by Senator John Tunney. and House Bill 
10318, introduced by Representative Bob Eckhardt, are objectionable as being 
both overly burdensome to industry and detrimental to the public interest. 

These bills could impose costly and unnecessary testing requirements with 
respect to the new and existing chemical substances, in many cases without re- 
gard to the relative level of risk which may be involved. They require the pro- 
mulgation of rules governing the production and use of chem.ical substances on 
the mere possibility that these substances may present an unreasonable risk, 
and do not even require the preparation of an economic impact statement al- 
though the regulations could ban the production of a chemical, shut down the 
plants making it or using it, and terminate the jobs involved. The bills also 
would create uncertainty in the enforcement of Federal laws by encouraging 
duplicative action by different Federal agencies and would permit the EPA to pick 
and choose among potentially applicable laws. 

These are correctible defects. In fact, legislation which met many of these 
concerns passed the House of Representatives in the last Congress. A similar bill, 
H.R. 7664, has been introduced in the current Congress by Rep. John McCollister. 
We urge Members of Congress to support, actively legislation like the McCollister 
bill, H.R. 7664, and to work against the enactment of legislation which would 
threaten entire industries with needless regulation without offering added assur- 
ance of public safety. 



252 



I hope that you also will voice your concern to Members of the Committee now 
considering toxic substances control bills. 

I am enclosing a summary of industry's concerns over the aforementioned bills 
which provides more detailed information w ith respect to such concerns. In addi- 
tion, I shall be most happy to discuss them with you at any time you are in this 
area. 

Thank you for your assistance. 
Sincerely yours, 

A. T. MOEPHY. 



Summary of Some of the Major Concerns With Toxic Substances Control 

Legislation 

(H.R. 10318 (Eckhardt)— S. 3149 (Tunney)) 

1. Testing. [Sec 4] The Administrator of EPA should be permitted to require 
testing of chemical substances where necessary to protect against an unreason- 
able risk to health or the environment. However, both H.R. 10318 and S. 3149 
require the Administrator to order testing if a chemical substance "may present" 
an unreasonable risk, and they thus threaten unnecessary testing which is both 
costly and time-consuming. Both bills contain undesirable provisions for es- 
tablishment of extensive public priority lists of suspect chemicals, without ap- 
propriate procedural safeguards, which arbitrarily restrict the EPA Admin- 
istrator's authority and could unfairly damage or destroy a product's trade 
acceptance and reputation before recommended testing could be completed. 

2. Premarket Screening. [Sec. 5] Premarket screening, which for all practical 
purposes results in an EPA premarket approval, should be limited to those chemi- 
cals that are likely to pose a substantial danger — an unreasonable risk of death 
or severe or widespread harm. S. 3149 requires premarket screening — and threat- 
ens indefinite delay of new product development and marketing — with respect 
to all new chemical substances and significant new uses of established sub- 
stances, regardless of the risks involved. Under H.R. 10318 screening jjiay be re- 
quired on the mere possibility of an unreasonable risk. 

3. Regulation. [Sec. 6] A sound, balanced approach to controlling toxic sub- 
stances should require that regulatory actions be aimed at the distribution and 
use of those substances only when necessary to prevent an unreasonable risk 
to health or the environment. Both pending bills require the promulgation of 
such rules on the mere possibility that a chemical substance presents or con- 
tributes to an unreasonable risk. Under certain circumstances they can be put 
into effect immediately. They do not require the Administrator to use the least 
burdensome regulation required to prevent the risk. They do not require the 
Administrator to include an economic impact statement in any such rule, even 
if the rule bans the production of a substance, shuts down the plant making and 
using it, and ends the jobs involved in manufacture and use. 

4. Unreasonable RisJx. [Sec. 6] S. 3149 attempts a legislative definition of 
"unreasonable risk to human health and the environment." The definition pro- 
posed by S. 3149 is both vague and unworkable. H.R. 10318 also unwisely and 
unnecessarily broadens the concept of unreasonable risk by making the concept 
applicable even if the substances make a minute contribution to any risk, even 
a naturally occurring one. 

5. Imminent Hazard. [Sec. 7] Of serious concern is that the total impact of 
Sections 4, 5, 6, and 7 of H.R. 10318 and S. 3149 is in the direction of a zero risk 
concept, that is, protection of society from all possible health hazards. Yet all 
social progress is predicated on some level of risk assumption. Our good quality 
and style of life today would never have been achieved by a no-risk approach 
to progress. What is essential is that we avoid unreasonable risks and we sup- 
port legislation to this effect — not legislation reflecting a zero risk, no-hazard 
approach. 

6. Reporting. [Sec. 8] Toxic substances control legislation should empower the 
regulatory agency to obtain information from manufacturers as necessary to 
facilitate its administration of the law, but avoid overburdensome paperwork 
requirements. S. 3149 unreasonably requires both the immediate transmittal to 
EPA and the retention of all health and safety data, Including any letters from 
anyone concerning an alleged adverse effect of a chemical substance and any re- 
port of illness allegedly related to chemical exposure. H.R. 10318 imposes crimi- 



253 



nal penalties for violation of the impossibly vague requirement that a manufac- 
turer immediately inform the Administrator about any information which 
"reasonably supports" the conclusion that a chemical substance presents an 
unreasonable risk. In addition, both bills require manufacturers to prepare a list 
of all chemical studies conducted by or for them, regardless of their need, sig- 
nificance, or validity. 

7. Citizen Petitions. [Sec. 21] H.R. 10318 and S. 3149 give any person the right 
to petition the Administrator to commence a proceeding for the issuance of a 
rule under various sections of the legislation, and, more remarkably, give any 
such person the right to a de novo trial in Federal district court if the Admin- 
istrator does not accede to the request. This means that every Federal court 
could be turned into a mini-EPA, forced to hear complex, scientific testimony 
presented by any person with whom EPA disagreed. This is not judicial review 
of agency action ; there is no weight given to the Administrator's discretion or 
exi)ertise. Moreover, the very existence of this type review threat further erodes 
the likelihood that the Administrator will be in a position to make reasonable 
and prudent judgments in discretionary areas — judgments which are essential 
in administering any of the proposed bills because of the severe economic and so- 
cial consequences that could result from any significant action. 

8. Overlapping Lairs. [Sec. 9] Sound legislation should provide for the control 
of toxic substances, to the greatest extent possible, through existing regulatory 
authorities. H.R. 10318 and S. 31-J9 would create uncertainty in the enforcement 
of Federal laws by encouraging duplicative action by Federal agencies and, with 
respect to laws administered by the Administrator, would permit the Admin- 
istrator to ''pick and choose" among potentially applicable laws. 

9. Scope and Coverage. [Sec. 3J lioth S. 3149 and H.R. 10318 are, at least 
potentially, applicable to every chemical substance and every mixture of chemical 
substances. Since every substance, product or commodity is covered by 
the bill's definitions of chemical substance and mixture, great care must be 
taken in drafting the legislation to prevent its unfair and unnece.ssary appli- 
cation to chemicals that do not present significant risks. Neither bill reflects 
this care. It is unnecessary for the legislation to cover mixtures of chemical 
substances, research and test chemicals, reagents, or catalysts, unless they pose 
an unreasonable risk. 

10. Confidential Industry Data. [Sec. 14] To prevent unfair competitive damage, 
the legislation must provide careful protection against public disclosure for con- 
fidential company data with respect to production, chemical composition, mar- 
keting plans and other business secrets, 

11. All of the above concerns are correctal)le defects. In fact, legislation which 
met many of the.se concerns passed the Hou.se of Representatives in the last 
Congress. A similar bill, H.R. 7664, has been introduced in the current Congress 
by Rep. John McCollister. We urge Members of Congre.«?s to actively suppf)rt 
legislation like the McCollister bill, H.R. 7664, and to work against the enact- 
ment of legislation which would threaten entire industries with needless regu- 
lation without offering added assurance of public safety. 

Mr. TiiURMOXD. I wish to say too that I think the administration's 
position on this bill is a sound position. Tliis is the administration's 
position : 

While the Administration has taken the lead since 1971 in urging legislation 
to control toxic substance.^, it strongly oppo.ses enactment of this bill. 

S. 3149 unnecessarily overburdens both the regulatory agency and the regu- 
lated industry by : 

Requiring premarket notification on all new substances regardless of whether 
or not they are even potentially toxic. 

Requiring the regulatory agency to make detailed findings even on those sub- 
stances s\iiich it feels need no regulation or further testing. 

The bill does not adequately protect against the unauthorized relea.se of trade 
.secrets and proprietary information. Such protection is critical to the effective 
work of the toxic controlled program. Also provides for citizen petition, citizen 
civil action against nondiscretionary acts, and compensation for attorney's fees. 

These provisions unnecessarily invite further litigation without any major 
benefit over the normal judicial review procedures in the legislation. 

Mr. President. I think the administration is on sound ground here. 
As it says, the administration has taken the lead since 1971 in urging 



254 



legislation to control toxic substances, but it cannot support this bill, 
and, in fact, strongly opposes the enactment of the bill for the reasons 
I have just stated. 

For those reasons, Mr. President, and others I shall not take time 
now to mention, I shall vote against this measure. All of us have a sin- 
cere desire to protect the public from toxic chemical substances, but 
this legislation goes much further than prudence and the public inter- 
est require. 

Mr. TuxNEY. Mr. President, I make it clear that the legislation that 
I hope we pass in a few minutes is designed to assure that chemicals 
that are used in high volume are going to be tested for safety. 

As a matter of fact, even low volume chemicals will be tested if there 
is concern as to their effect on the environment or on human health. 

Section 4 states that if a chemical substance or mixture may present 
a significant human or environmental exposure because of production 
in substantial quantities or for other reasons, and the substance or mix- 
ture may perhaps present an adverse effect on health and the environ- 
ment, the Administrator must require testing if there are insufficient 
data or experience to reasonably determine or predict the effects and 
testing is necessary to develop the data. 

So there should be no question in anyone's mind that, where we have 
substantial amounts of a chemcial being produced and being disbursed 
throughout the environment, the Administrator is required to order 
testing where he does not have adequate data to be able to make up his 
mind on the evidence and where the testing is needed to develop the 
data. 

I think it is very clear. 

Mr. Hartke. Mr. President, I quite agree with the Senator from Cal- 
ifornia. There is no question that one of the problems we have in Amer- 
ican society today is that we are increasingly using a volume of 
chemicals which is absolutely going to astonish most individuals and as 
far as the people are concerned provide for them an exposure which 
might not otherwise be dangerous but simply by the sheer volume of 
the chemical exposure present a hazard to the health or to the environ- 
ment of this Xation. 

The Administrator is required to go ahead and deal with this type 
of situation. In other words, he will, in fact, address himself to this 
potential hazard and will make the necessary testing, necessary reports, 
and necessary findings. 

I point out that generally speaking we will have in here, as I under- 
stand it only one reference to specific items. Generally speaking, I think 
it is better legislative procedure to keep legislation general and not deal 
with specific items. For that reason, I think we are justified in not put- 
ting an amendment in this bill which really specifically deals with high 
volume chemicals. On the other hand, I think that if it is omission as a 
specific amendment could be interpreted as an indication by Congress 
that we did not intend to cover such items, then I would feel compelled 
to make sure that Ave had an amendment of that nature in the bill. But 
as has been indicated by the Senator from California, under section 4, 
the testing of chemical substances and mixtures, it is fully anticipated 
that the Environmental Protection Administrator will require that 
testing and will act accordingly. 



255 



Mr. TuNXEY. Mr. President, a question has been raised concerning 
the possibility that a State law, a State effluent standard, for example, 
established pursuant to the Federal AVater Pollution Act would be pre- 
empted if there were in existence a toxic substance rule pertaining to 
the manufacture, distribution, or disposal of a chemical substance that 
was subject to the effluent standard. That emphatically is not the case. 
The State is only preempted under the bill from establishing a stand- 
ard relating to the manufacture, distribution, or disposal inconsistent 
with the standards authorized under section 6. State effluent or air pol- 
lution standards pursuant to Federal law would not be preempted by 
section 13. 

Mr. Pearson. Mr. President, I ask unanimous consent to have 
printed in the Record a statement by the distinguished Senator from 
Connecticut (Mr. Weicker). 

The Presiding Officer. Without objection, it is ordered. 

Statement of Senator Weicker 

I believe the Toxic Substance Contol Act is the most important piece of envi- 
ronmental le^slation to come before the Congress this year. It places the respon- 
sibility of proving the safety of new chemicals right where it belongs — on the 
government. With 500 to 1.000 new chemical substances being introduced into 
commercial use every year, the government must have the power to act. The 
illness and death attributed to kepone, vinyl chloride, asbestos, and other chem- 
icals is tragic evidence that that power does not now exist, 

I have long supported and I am a cosponsor of this measure which places as 
one of our greatest environmental priorities the protection of the public against 
the health hazards associated with dangerous chemicals, 

LEGISLATTVE HISTORY TO ACCOMPANY MODEL ATTORNEYS^ FEES PROVISION 

Mr. TuNNEV. Mr. President, attorneys' fees provisions appear in a 
number of places throughout this legislation [e.g., Sec. 19(c)(3)]. 
These provisions allow a court to award costs of suit and reasonable 
fees where ''appropriate." These provisions are very important to the 
proper vindication of rights under this legislation. I would like to offer 
some explanation which in my opinion will clarify the operation o.f 
those provisions. 

Until recently, the courts often provided for effective actions by pri- 
vate citizens through the award of costs and fees, even in the absence 
of specific statutory authorization, under the ''private attorney gen- 
eral" rationale. However, in a recent decision. Alyeska Pipeline Serv- 
ice Co. against Wilderess Society, the Supreme Court held that — 

Courts lacked discretionary power to award attorneys' fees to petitioners who 
sought to vindicate "imi)ortant statutory rights for all citizens" , . . unless there 
was specific statutory authorization for such awards , . . The circumstances under 
which attorneys' fees are to be awarded and the range of discretion in the court 
for making those awards are matters for Congess to detemine. 

In light of that decision, the fees and costs provisions of this legisla- 
tion follow the precedent of over 50 Federal statutes in permitting fee 
shifting by the courts. 

This provision Avould allow an award of fees and costs to any party 
when "appropriate," a word which should liberally construed to effec- 
tuate the purposes of this act. Thus, in typical circumstances, the court 
should follow prevailing case law which holds that a successful plain- 



256 



tiff "should ordinarily recover an attorneys' .fee unless special circum- 
stances would render such an award unjust." Newman v. Piggie Park 
Enterjnnses, Inc., 390 U.S. 400, 402 (1968) (per curiam). "Plaintiff" 
in this sense is used to mean the parties seeking to enforce the rights 
granted by this section and can include an intervenor, or a defendant 
in some cases. See e.g., Shelley v. Kramer, 334 U.S. 1 (1948). 

In exceptional circumstances, fees and costs might also be awarded 
to defendants where they must "defend against unreasonable, friv- 
olous, meritless or vexations actions * * *" United States Steel Corp. v. 
United States, 385 F. Supp. 346, 348 (W.D. Pa. 1974). Where plain- 
tiff's proceeding is brought in good faith or on the advice of component 
counsel, fees and costs would ordinarily be denied to a prevailing 
defendant. Richardson v. Hotel Corporation of America. 332 F. Supp. 
519 (E.D. La. 19711), aff'd 468 F. 2d 951 (5th Cir. 1972). The stand- 
ard for awarding fees and costs to a prevailing defendant is not the 
same as for a plaintiff because, if it were, the risk, to the average citizen 
of bringing suit under this section would be so great it would discour- 
age such suits. 

Fees and costs would be awarded to a "successiful plaintiff" under 
this provision where there was a final court order granting the relief 
requested by plaintiffs, or as a matter of interim relief pending the 
outcome of the case. The provision does not require the entry of a final 
order before fees or costs mav be recovered. See Bradley v. School 
Board of the City of Richmond, 416 U.S. 606 (1974) ; Mills v. Electric 
Auto-Lite Co., 396 U.S. 375 (1970). Such awards are especially im- 
portant where a party has prevailed on an important matter in the 
course of the litigation even where he does not ultimately prevail on 
all the issues. See Bradley, supra, and Mills, supra. For purposes of 
the award of fees and costs, it is "appropriate" to make awards where 
the parties have vindicated rights through a consent judgment, or 
without formally obtaining relief, or where such award is in the public 
interest without regard to the outcome of the litigation. Kopet v. 
Esquire Realty Co., 523 F. 2d 1005 (2d Cir. 1975) ; ParJiam, v. South- 
western Bell Telephone Co.. 433 F. 2d 421 (8th Cir. 1970) ; Richards v. 
Griffith Rubier Mills. 300 F. Supp. 338 (D. Ore. 1969) ; Thomas v. 
Honeyhrook Mints, Inc., 428 F. 2d 981 (3d Cir. 1970). 

By specifying a general rule for the amount of fees to be awarded, 
this provision requires the method of calculating fees be no different 
than that now being utilized in other fields of law as, for example, 
antitrust and securities regulation litigation. The "actual time" spent 
is that reasonably calculated to advance the client's interest. The Stan- 
ford Daily v. Zurcher, 64 F.R.I). 680 (N.D. Cal. 1974) , and the amount 
can be adjusted for factors including, inter alia, the contingent nature 
of the success or the quality of the work performed. Lrndy Bros. 
Builders v. American Radiator (ۥ Standard Sanitary Corp.. 487 F. 2d 
161 (e3d Cir. 1973), on remand, 382 F. Supp. 999 (E.D. Pa. 1974), or 
benefits to the public from the suit. Davis v. County of Los Angeles, 
8 E.P.D. 9444 (CD. Cal. 1974). Fees should not be reduced merely 
because the attorneys are salaried employees of public interest and/or 
foundation -funded law firms. 

Fees and costs awarded under this provision may be assessed against 
the United States, including any of its agencies and officers acting in 
an official capacity, the same as against a private party. 



257 



Finally, since expert witnesses are o.f ten needed to make an adequate 
presentation to a court, such fees are also provided for in this statute. 
They would be in addition to those now provided in 28 U.S.C. 1920 
and 28 U.S.C. 1821. 

The policy outlined above should apply to the procedures under 
section 23 to the extent applicable. 

Mr. Xelsox. Mr. President, I would like to take this opportunity 
to elaborate and clarify an important point contained in the com- 
mittee's report. On page 26, in reference to amendment Xo. 21 [Sec. 
17(a)] sponsored by the Senator from Michigan (Mr. Gary Hart), 
the Senator from Illinois (Mr. Percey), and myself, regarding the 
burden of proof a plaintiff must sustain in order to gain relief under 
the laws administered by the Environmental Protection Agency, the 
report states : 

The amendment attempted to rectify a three judge panel decision of the 
Eighth Circuit concerning relief set against the Reserve Mining Company. As 
decisions reached by the Courts in subsequent appeals is consistent with the 
requirements of Amendment No. 21 the amendment is unnecessary. 

I believe it has for many years been the law that courts have full 
authority to protect human life and health when either is seriously 
threatened. However, some courts have expressed doubts about what 
the law is, and how it should be interpreted. I believe that any court of 
law or anv governmental administrator when faced with a real risk of 
serious injury to human beings would have to make sure that the 
danger is removed. 

Amendment Xo. 21 is aimed at those situations where some evidence 
of a serious potential hazard exists but the evidence is inconclusive. 
Amendment Xo. 21 would prohibit a court from denying equitable 
relief under any kct administered by the EPA where a risk to public 
health is alleged and established. 

Amendment X'o. 21 attempts to clarify existinjr law. This legislation 
does not cliange the law. If enacted, this legislation would only clarify 
and reinforce existing tenets of congi-essional policy and existing law, 
tliat precautionary action shall be taken to prevent ])erceivcd harm 
where evidence of a serious potential hazard exists but the conclusive 
scientific evidence is not yet available. 

On the merits of the issue, I agree with the committee that the law 
is clear and that the Eighth Circuit Court of Appeals sitting en banc, 
in reviewing the Resen^e Mining Co. decision, has indeed rectified 
many of the mistakes contained in the ori2:inal eighth circuit decision. 
However, susequent court decisions reveal that the courts are still not 
clear as to Congress' intent as well as what the law requires in 
these most serious environmental health cases. 

On March 19. 1076, the F.S. Court of Appeals for the District of 
Columbia sitting en banc affirmed an Environmental Protection 
Afifency reinilation regarding the reduction of lead levels in gasoline. 
The 5 to 4 decision deals specifically with the question addressed by 
amendment Xo. 21. 

The Administrator determined that leaded gasoline automotive 
emissions present "a sis:nificant risk of harm" to the public 
health * * *. Based on this finding, the Administrator issued the 
re;2:ulations requiring annual reductions in the lead content of leaded 
gasoline. 



258 



The Court held that— 

In applying the "will endanger" standard the Administrator is authorized to 
assess risks of harm and, where the risk is found significant, to act to prevent 
the harm from happening. Thus the regulatory action under this precautionary 
statute should precede, and hopefully prevent, the perceived harm. 

The petitioners in this case argued that the "will endanger" stand- 
ard requires a high quantum of actual proof, proof of actual harm 
rather than a "significant risk of harm." The Court stated : 

It is our view that the Administrator's interpretation of the standard is the 
correct one. 

The court held — 

The meaning of "endanger" is not disputed. Case law and dictionary definition 
agree that endanger means something less than actual harm. When one is 
endangered, harm is threatened ; no actual injury need ever occur ... a statute 
allowing for regulation of the force in danger is, necessarily, a precautionary 
statute. Regulatory action may be taken before the threatened harm occurs; 
indeed, the very existence of such precautionary legislation would seem to 
demand that regulatory action precede, and, optimally, prevent, the perceived 
threat. 

The Court specifically refers to the en banc decision of Reserve, 
Mining/ Company v. EPA, 514 F. 2d 492 (8th Cir. 1975) (en banc), 
in inte^rpreting the meaning of "endanger." The eighth circuit's unani- 
mous conclusion fully supports the District of Columbia Appeals 
Court standard of "will endanger." The eighth circuit held: 

In the context of this environmental legislation, we believe that Congress used 
the term "endangering" in a precautionary or preventive sense, and, therefore, 
evidence of potential harm as well as actual harm comes within the preview of 
that term, 

( See Reserve Mining Campcmy vs. EPA, supra, 514 F. 2d at 528) 

The District of Columbia Appeals Circuit Court held : 

. . . based on the meaning of the statute . . . and the Reserve Mining prece- 
dent, we conclude that the "will endanger" standard is precautionary in nature 
and does not require proof of actual harm before regulation is appropriate. 

In the Reserve Mining case, the eighth circuit allowed regulation of 
the daily discharge of 67,000 tons of taconite tailings into Lake 
Superior on only a "reasonale" or "potential" showing of danger, 
hardly the probable finding urged by the petitioners in the EPA lead 
case as a proper reading of the "endanger" language. The appeals 
court states: 

Reserve IMining convincingly demonstrates that the magnitude of risks suffi- 
cient to justify regulation is inversely proportional to the harm to be avoided. 

eTudije Wright, in commenting for the majority of the D.C. circuit 
regarding lead levels in gasoline, correctly has viewed the congres- 
sional policy and has correctly interpreted the law in determining 
what standard of evidence is renuired before appropriate relief can 
be fifranted. However, Judge Wilkey, who joined with Judge Tamm 
and Robb in dissent, raised questions regarding what standard of 
proof is required before relief is granted. His dissent states, in part : 

For the Court's opinion to hold that the Administrator can dispense with proof 
of actual harm, i.e.. what has occurred in the past, and can nevertheless vsomehow 
determine potential harm, is to grant the plaintiffs license for the widest specula- 
tion we have always under scientific conclusions, above all demand that proof by 
events recorded and observed. 



259 



Apparently, the law is not sufficiently clear if our judges on the Dis- 
trict of Columbia Circuit Court of Appeals specifically disagreed with 
what burden of proof must be sustained by a plaintiff before appro- 
priate relief may be granted. HowcAxr clear the Eighth Circuit Court 
of Appeals and the majority of the District Court of Appeals and 
j Members of Congress believe the law is, as currently drafted, clarifica- 
I tion would be helpful. Amendment No. 21 is not as unnecessary as the 
committee report would indicate. There is question in the judiciary as 
to what the law is. I believe the law is clear, and I hope this legislative 
history will help the courts in understanding Congress intent to pro- 
tect the public's health before significant harm can occur. At the very 
least, the dissent by Judge Wright and others reemphasize the merit 
in enacting legislation to make Congress intent unmistakably clear. 

Mr. President, I ask unanimous consent that a Library of Congress 
American Law Division opinion on this issue be printed in the Record. 

There being no objection, the material was ordered to be printed in 
the Record, as follows : 

Congressional Research Service, 

Washington, D.C., March 25, 1976. 
To : Hon. Gaylord Nelson, Attention : Jeff Nedelman. 
From : American Law Division, 
I Subject : Reserve Mining and Ethyl Corporation Interpretation of Findings Nec- 
I essary to Show That a Pollutant is "Endangering" the Public Health. 

This responds to your request for an analysis of the above-noted subject as in- 
terpreted by the decision of the United States Court of Appeals for the Eighth 
Circuit in Reserve Mining Co. v. United States, 417 F.2d 492 (8th Cir. 1975) 
{en banc), and by the decision of the United States Court of Appeals for the 
District of Columbia in Ethyl Corp. v. Environmental Protection Agency, No. 
78-2205, March 19, 1970 (en banc). The 5-judge panel of the Eighth Circuit was 
unanimous in its decision ; the 9-judge panel of the District of Columbia Circuit 
was split 5 to 4. 

Both the 8th Circuit and the majority of the D.C. Circuit agreed that the con- 
cept of endangerment includes a precautionary or preventive element, so that 
proof of potential harm can establish endangerment, and it is not necessary to 
establish that actual harm has already occurred. In this context the language at 
issue in Reserve Mining was former section 1160(g) (1) of Title 33, U.S.C. Code, 
predicating an abatement action on a finding that "pollution of water ... is en- 
dangering the health or welfare . . ." At issue in Ethyl Corp. was section 211 
of the Clean Air Act, 42 U.S.C. § 1857f-6c, permitting the Administrator of EPA 
to regulate a fuel additive "if any emission products of such fuel or fuel additive 
will endanger the public health or welfare." 

The following analysis appears in the 8lh Circuit's opinion in Reserve Mining, 
514 F.2d at 528-529; 

[20] An action under the FWPCA requires proof of an additional element. 
The United States must establish that the water pollution which is violative of 
state water quality standards is also "endangering the health or welfare of per- 
sons." § 1160(g) (1). 

In this review, we must determine whether "endangering" within the meaning 
of the FWPCA encompasses the potential of harm to public health in the degree 
shown here. 

[21, 22] Provisions of the FWPCA are aimed at the prevention as well as the 
cure of water pollution. The initial sentence of the FWPCA reads : 

The purpose of this chapter is to enhance the quality and value of our water 
resources and to establish a national policy for the prevention, control, and abate- 
ment of water pollution. [33 U.S.C. § 1151(a).] 

The term "endangering," as used by Congress in § 1160(g) (1), connotes a lesser 
risk of harm than the phrase "imminent and substantial endangerment to the 
health of persons" as used by Congress in the 1972 amendments to the FWPCA, 
33 U.S.C. § 1364 (Supp. 1974). 



260 



[23] In the context of this environmental legislation, we believe that Congress 
used the term "endangering" in a precautionary or preventive sense, and there- 
fore, evidences of potential harm as well as actual harm comes within the pur- 
view of that term. We are fortified in this view by the flexible provisions for in- 
junctive relief which permit a court "to enter such judgment and orders enforc- 
ing such judgment as the public interest and the equities of the case may require." 
33 U.S.C. § 1160(c) (5). 

We deem pertinent the interpretation given to the term "endanger" by Judge 
Wright of the District of Columbia Circuit in his analysis of the congressional 
use of the word "endanger" in the context of a provision of the Clean Air Act. 
42 U.S.C. § 1857f-6c(c) (1) (A) (1970). 

Judge Wright observed : 

The meaning of "endanger" is, I hoi)e, beyond dispute. Case law and dictionary 
definition agree that endanger means something less than actual harm. When one 
is endangered, harm is threatened; no actual injury need ever occur. 

******* 
"Endanger," * * * is not a standard prone to factual proof alone. Danger is a 
risk, and so can only be decided by assessment of risks. 

***** * * 

[A] risk may be assessed from suspected, but not completely substantiated, 
relationships between facts, from trends among facts, from theoretical projec- 
tions from imperfect data, or from probative preliminary data not yet certifiable 

as "fact." [Ethyl Corporation v. Environmental Protection Agency, F. 2d 

, (D.C. Cir., Jan. 28, 1975) (dissenting op. at , ) (emphasis in 

original) (footnote omitted).] 

Although the Supreme Court has not interpreted the concept of "endangering" 
in the context of an environmental lawsuit, it has emphasized the importance 
of giving environmental legislation a "common-sense" interpretation. Mr. Justice 
Douglas, writing for the Court, said : 

"This case comes to us at a time in the Nation's history when there is greater 
concern than ever over pollution — one of the main threats to our free-flowing 
rivers and to our lakes as well * * * [W]hatever may be said of the rule of 
strict construction, it cannot provide a substitute for common sense,, ^precedent, 
and legislative history." [United States v. Standard Oil Co., 384 U.S. 224, 225, 86 
S.Ct. 1427, 1428, 16 L.Ed.2d 492 ( 1966) .] 

See United States v. RepubUc Steel Corp., 362 U.S. 482, 491, 80 S.Ct. 884, 4 L.Ed. 
2d 903 (1960). 

[24, 25] The record shows that Reserve is discharging a substance into Lake 
Superior waters which under an acceptable but "unproved medical theory may be 
considered as carcinogenic. As previously discussed, this discharge gives rise to 
a reasonable medical concern over the public health. We sustain the district 
court's determination that Reserve's discharge into Lake Superior constitutes 
pollution of waters "endangering the health or welfare of persons" within the 
terms of §§ 1160(c) (5) and (g) (1) of the Federal Water Pollution Control Act 
and is subject to abatement. 

The Ethyl Corp. decision cited in Reserve Mining, supra, was vacated. Judge 
Wright, whose dissent in the vacated decision is quoted above in Reserve Mininf/, 
wrote the majority opinion in the March 19, 1976 en bane decision in Ethyl Corp. 
Judge Wright reiterated his previous analysis, and provided the following sum- 
mary (slip opinion, pp. 53-56) ; 

These cases, recognizing as they do the developing nature of environmental 
medicine, fortify our analysis of the "will endanger" language of Section 211. 
Where a statute is precautionary in nature, the evidence difficult to come by, 
uncertain, or conflicting because it is on the frontiers of scientific knowledge, the 
regulations designed to protect the public health, and the decision that of an ex- 
I>ert administrator, we will not demand rigorous stei>by-stej) proof of cause and 
effect. Such proof may be impossible to obtain if the precautionary purpose of 
the statute is to be served. Of course, we are not suggesting that the Administra- 
tor has the power to act on hunches or wild guesses. Amoeo makes it quite clear 
that his conclusions must be rationally justified. Amoco Oil Co. v. EPA . supra, 163 
U.S. App. D.C. at 180-181, 501 F.2d at 740-741. However, we do hold that in such 
cases the Administrator may assess risks. He must take account of available facts. 



261 



of course, but his inquiry does not end there. The Administrator may apply his 
expertise to draw conclusions from suspected but not completely substantiated, 
relationships between facts, from trends among facts, from theoretical projec- 
tions from imperfect data, from probative preliminary data not yet certifiable as 
"fact," and the like. We believe that a conclusion so drawn — a risk assessment — 
may, if rational, form the basis for health-related regulations under the "will 
endanger" language of Section 211."* 

All of this is not to say that Congress left the Administrator free to set policy 
of his own terms. To the contrary, the policy guidelines are largely set, both in 
the statutory term "will endanger" and in the relationship of that term to other 
sections of the Clean Air Act. These prescriptions direct the administrator's 
actions. Operating within the prescribed guidelines, he must consider all the in- 
formation available to him. Some of the information will be factual, but much 
of it will be more speculative — scientific estimates and "guestimates" of prob- 
able harm, hypotheses based on still-developing data, etc. Ultimately he must 
act, in part on "factual issues," but largely "on choices of policy, on an assess- 
ment of risks, [and] on predictions dealing with matters on the frontiers of 
scientific knowledge * * *." Amoco Oil Co. v. EPA, supra, 163 U.S. App. D.C. at 
181, 501 F.2d at 741. A standard of danger — fear of uncertain or unknown harm — 
contemplates no more. 

That other interpretations of the "will endanger" or "endangering" standard 
are possible is apparent from a reading of Judge Wilkey's dissent in Ethyl 
Corp., joined by Judges Tamm and Robb. Judge Wilkey rejected the distinction 
"between actual and potential between past and future harm." and continued : 

The Administrator is dealing with a coniinuing situation. If there can be found 
potential harm from lead in exhaust emissions, the best (and only convincing) 
proof of such potential harm is what has occurred in the past (either in 50 years 
of practical usage or in laboratory experimentation), from which the Adminis- 
trator can logically deduce that the same factors will produce the same harm in 
the future. For the court's opinion to hold that the Administrator can dispense 
with proof of actual harm, i.e., what has occurred in the past, and can neverthe- 
less somehow determine potential harm, is to grant the plainest license for the 



^ It bears emphasis that what is herein describe as "assesment of risk" is neither 
unprecedented nor unique to this area of law. To the contrary, assessment of risk is a 
normal part of judicial and administrative fact-finding. Thus KPA is not attempting to 
expand its powers ; rather, petitioners seek to constrict, the usual flexibility of the fact- 
finding process. Petitioners argue that the Administrator must decide that lead emis- 
sions "will endanger" the public health solely on "facts," or, in the words of the division 
majority, by a "chain of scientific facts or reasoning leading (the Administrator) inelucta- 
bly to this conclusion * * *." Division op. at 59. Petitioners demand sole reliance on 
scientific facts on evidence that reputable sceintific techniques certify as certain. Typically. 
.1 scientist will not so certify evidence unless the probability of error, by standard 
statistical measurement, is less than 5 percent. That is, scientific fact is at least 95 percent 
certain. 

Sucli certainty has never characterized the judicial or the administrative process. It 
mav be that the "beyond a reasonable doubt" standard of criminal law demands 95 percent 
certainty. Cf. McGill v. United States, 121 IT.S. App.D.C. 179. 185 n.6, .348 F.2d 791. 
797 n.f) (1965) But the standard of ordinary civil litigation, a preponderance of the 
evidence,, demands only 51 percent certainty. A jury may weigh conflicting evidence and 
certify as adjudicative (although not scientific) fact that which it bei;<*ves is more 
likely" than not. Since Rctierve Mining was adjudicated in court, this standard applied to 
the court's fact-finding. Inherently, such a standard is flexible ; inherently, it allows 
tlie fact-finder to assess risks, to measure probabilities, to make subjective judgments. 
Nonetheless, the ultimate finding will be treated, as law. as fact and will be affirmed if 
based on substantial evidence, or if made by a judge, not clearly erroneous. 

The standard before administrative agencies is no less flexible. Agencies are not limited 
to scientific fact, to 95 percent certainties. Rather, they have at least the same fact- 
finding powers as a jury, particularly when, as here, they are engaged in rule-making. 

Looking to the future, and commanded by Congress to make policy, a rule-making 
agency necessarily deals less with "evidentiary" disputes than with normative conflicts, 
projections from imperfect data, experiments and simulations, educated predictions, differ- 
ing assessments of possible risks, and the like. 

Adwco Oil Co. V. EPA. supra note 2, 16.S U.S. App.D.C. at 175, 501 F.2d at 735. An 
agencv's finding of fact differs from that of a jury or trial judge primarily in that it is 
accorded more deference by a reviewing court. Flee note 74 infra. Thus, as a matter of 
administrative law. the Administrator found as fact that lead emissions "will endanger" 
the public health. That in so doing he did not have to rely solely on proved scientific fact 
is inherent in the requirements of legal fact-finding. Petitioners' assertions of the need 
to rely on on "fact" confuse the two terminologies. We must deal with the terminology 
of law. not science. At law, unless the administrative or judicial task is peculiarly factual 
in nature, or Congress expressly commands a more rigorous finding, see 21 TT.S.C. § ,355 (d) : 
cf. pages 4,3-45 supra, assessment of risks as herein described typifies both the admin- 
istrative and the judicial fact-finding function, and is not the novel or unprecedented 
theory that petitioners contend. 



262 



wildest speculation. We have always thought scientific conclusions, above all, 
demanded proof by events recorded and observed. 

The court's second asserted dichotomy, risks versus facts, is equally indefensi- 
ble in logic. All true risk assessment is based on fact and nothing else. Those 
professional risk-assessors, the professional sports gambling fraternity, would 
smile at any other theory. To the extent that a hunch and intuition enter into 
any final decision, these are separate factors outside of any scientific risk 
calculation. 

Our colleagues apparently find it necessary to legitimatize the Administrator 
playing hunches. They assert, "Danger is a risk, and so must be decided by as- 
sessment of risk as well as by proof of facts." Of course the Administrator as- 
sesses risk — from the facts as he knows them. The question here is how much 
he knows. To the extent the agency found it necessary to make an "assessment of 
risk as well as [rely on] proof of facts," the agency was frankly just speculat- 
ing. No reviewing court can countenance this. If such agency decision is not 
"arbitrary and capricious," what decision could be? It is precisely a devotion of 
facts, not hunches, that distinguishes the professionals from the amateurs in 
assessing risks ; we deem the Administrator to have been intended by Congress 
to be a "professional." 

Geoege Costello, 
Legislative Attorney. 

Mr. Baker. Mr. President, American society has just recently re- 
alized the pervasiveness of the toxic chemical problem. The public is 
being exposed to substances that are potentially toxic during normal 
daily activities. 

Our present pollution laws do no guard effectively against this 
threat until these substances are already present in the environment. 
Government regulatory agencies in general have no authority to pre- 
vent exposure until after the substances have been manufactured and 
are in use. 

The measure before us today is an innovative legislative effort to 
evaluate and control these substances before they have a chance to be- 
come a problem. 

The bill provides a mechanism to evaluate these elements prior to 
production, thus halting the chain of events before it is started. It is 
hoped that this preventive action will yield an opportunity to the con- 
sumer, who has no resources to judge the long-range consequences of 
these chemicals This creates a mechanism to sort out the risks and 
benefits of these substances before harmful exposure. 

But while this regulatory approach is generally sound, it carries with 
it the potential for excessive administrative regulation and delay. It 
is imperative that this legislation not become a tool for causing un- 
necessary redtape for industry or government. 

The premarket screening process [Sec. 5] which is the key to this 
bill should not be used to cause unnecessary extensive testing in ad- 
vance of commercial production, preventing production of many 
needed products. This creates a heavy responsibility on those who ad- 
minister this act. Care must be taken to assure that the responsibility 
is carried out with fairness, not an overzealous use of administrative 
powers. 

******* 
The Presiding Officer. All time having been yielded back, the ques- 
tion is. Shall the bill pass ? 

The yeas and nays have been ordered, and the clerk will call the 
roll. 



263 



The assistant legislative clerk called the roll. 

Mr. Robert C. Byrd. I announce that the Senator from Indiana (Mr. 
Bayh), the Senator from Texas (Mr. Bentsen) , the Senator from Mis- 
sissippi (Mr. Eastland), the Senator from Alaska (Mr. Gravel), the 
Senator from Michigan (Mr. Philip A. Hart), the Senator from Colo- 
rado (Mr. Haskell), the Senator from Hawaii (Mr. Inouye), the Sen- 
ator from Washington (Mr. Jackson), the Senator from Wyoming 
(Mr. McGee), the Senator from New Hampshire (Mr. Mclntyre), the 
Senator from New Mexico (Mr. Montoya), the Senator from Utah 
(Mr. Moss), the Senator from Mississippi (Mr. Stennis), and the 
Senator from Iowa (Mr. Culver) are necessarily absent. 

I further announce that the Senator from Vermont (Mr. Leah}^), 
and the Senator from Louisiana (Mr. Long) are absent on official 
business. 

I further announced that, if present and voting, the Senator from 
Washington (Mr. Jackson), the Senator from Vermont (Mr. Leahy) 
and the Senator from Iowa (Mr. Culver) would each vote ''yea." 

Mr. Griffix. I announce that the Senator from Tennessee (Mr. 
Brock), the Senator from Massachusetts (Mr. Brooke), the Senator 
from New York (Mr. Buckley), the Senator fi-om Arizona (Mr. 
Fannin), the Senator from Oregon (Mr. ILatfield), the Senator from 
Nebraska (Mr. Hruska), the Senator from Nevada (Mr. Laxalt), the 
Senator from Maryland (Mr. Matliias), the Senator from Pennsyl- 
vania (Mr. Hugh Scott), the Senator from Virginia (Mr. Scott), 
and the Senator from Connecticut (Mr. Weicker) are necessarily 
absent. 

I further announce that, if present and voting, the Senator from 
Oregon (Mr. Hatfield), the Senator from Pennsylvania (Mr. Hugh 
Scott), and the Senator from Connecticut (Mr. Weicker) would each 
vote "yea.'' 

The result was announced — yeas 60, nays 13, as follows : 

[Rollcall Vote No. 103 Leg.] 
YEAS— 60 



Abourezk 


Glenn 


Xunn 


Allen 


Griffin 


l*ackwood 


Baker 


Hart, Gary 


Pastore 


Beall 


Hartke 


Pearson 


Biden 


Hathaway 


Pell 


Bumi)ers 


Hollings 


Percy 


Burdick 


Huddleston 


Proxmire 


Byrd, Harry F., Jr. 


Humphrey 


Randolph 


Byrd, Robert C. 


Javits 


Ribicofif 


Cannon 


Johnston 


Roth 


Case 


Kennedy 


Schweiker 


Chiles 


Magnuson 


Sparkman 


Church 


Mansfield 


Stafford 


Clark 


McClellan 


Stevens 


Cranston 


McGovern 


Stevenson 


Dole 


Metcalf 


Stone 


Durkin 


Mondale 


Taft 


Eagleton 


Morgan 


Talmadge 


Fong 


Muskie 


Tunney 


Ford 


Nelson 


Williams 



264 



NAYS— 13 



Bartlett 

Bellmon 

Curtis 

Domenici 

Garn 



Goldwater 

Hansen 

Helms 

McClure 

Symington 



Thurmond 

Tower 

Young 



Bayh 

Bentsen 

Brock 

Brooke 

Buckley 

Culver 

Eastland 

Fannin 

Gravel 



NOT VOTING— 27 

Hart, Philip A. 

Haskell 

Hatfield 

Hruska 

Inouye 

Jackson 

Laxalt 

Leahy 

Long 



Mathias 

McGee 

Mclntyre 

Montoya 

Moss 

Scott, Hugh 
Scott, William L. 
Stennis 
Weicker 



So the bill (S. 3149) was passed, as follows: 



S. 3149 

Be it enacted hp the Senate and House of Representatives of the United States 

of America in Congress assembled, 

SHORT TITLE AND TABLE OF CONTENTS 

Section 1. This Act may be cited as the "Toxic Substances Control Act". 
TABLE OF CONTENTS 

Sec. 1. Short title and table of contents. 

Sec. 2. Findings, policy, and intent. 

Sec. 3. Definitions and exclusions. 

Sec. 4. Testing of chemical substances and mixtures. 

Sec. 5. Premarket notification of chemical substances. 

Sec. 6. Regulation of chemical substances and mixtures. 

Sec. 7. Imminent hazards. 

Sec. S. Reporting and retention of information. 
Sec. 9. Relationship to other Federal laws. 

Sec. 10. Research, collection, dissemination, and utilization data. 
Sec. 11. Inspections and subpoenas. 
Sec. 12. Expo'-L. 

Sec. 13. Entry into customs territory of the United States. 
Sec. 14. Disclosure of data. 
Sec. 15. Prohibited acts. 
Sec. 16. Penalties. 

Sec. 17. Specific enforcement and seizure. 

Sec. 18. Pre-emption. 

Sec. 19. Judicial review. 

Sec. 20. Citizen's civil action. 

Sec. 21. Citizen's petitions. 

Sec. 22. National defense waiver. 

Sec. 23. Employee protection. 

Sec. 24. Studies. 

Sec. 25. State demonstration programs. 
Sec. 26. Administration of Act. 
Sec. 27. Authorization for appropriations. 
Sec. 28. Annual report. 



FINDINGS, POLICY, AND INTEREST 

Sec. 2. (a) Findings. — The Congress finds that — 

(1) humans and the environment are being exposed to a large number of 
chemical substances and mixtures each year ; 

(2) among the many chemical substances and mixtures constantly being 
developed and produced are some whose manufacture, processing, distribu- 
tion in commerce, use, or disposal may cause or contribute to an unreasonable 
risk of injury to health or the environment ; and 

(3) the effective regulation of such chemical substances and mixtures in 
interstate commerce necessitates the regulation of such chemical substances 
and mixtures in intrastate commerce as well. 



265 



(b) Policy. — It is the policy of the United States that — 

(1) adequate data should be developed with respect to chemical sub- 
stances and mixtures concerning their effect on human health and the 
environment and that such data development should be the responsibility of 
those who manufacture and those who process such chemical substances and 
mixtures ; 

(2) adequate authority should exist to regulate chemical substances and 
mixtures which cause or contribute to an unreasonable risk of injury to 
health or the environment, and to take action with respect to chemical 
substances and mixtures which are imminent hazards ; and 

(3) authority over chemical substances and mixtures should be exercised 
in such a manner as not to impede unduly or create unnecessary economic 
barriers to technological innovation while fulfilling the primary purpose of 
this Act to assure that such innovation and commerce in such chemical sub- 
stances and mixtures do not cause or contribute to an unreasonable risk of 
injury to health or the environment. 

(c) INTENT OF Congress. — It is the intent of Congress that the Administrator 
shall carry out this Act in a reasonable and prudent manner, and that the Admin- 
istrator shall consider the environmental, economic, and social impact of any 
action the Administrator takes or proposes to take under this Act. 

DEFINITIONS AND EXCLUSIONS 

Sec. 3. (a) Definitions. — As used in this Act : 

(1) The term "Administrator" means the Administrator of the Environmental 
Protection Agency. 

(2) (A) Except as provided in subparagraph (B), the term "chemical sub- 
stance" means — 

(i) any organic or inorganic substance of a particular molecular identity 
including a combination of .such substances occurring as a result of a chemi- 
cal reaction, or 

(ii) any element or uncombined radical. 
(B) Such term does not include — 

(i) any mixture, 

(ii) any pesticide (as defined in the Federal Insecticide, Fungicide and 
Rodenticide Act) when manufactured or distributed in commerce for use as 
a pesticide, 

(iii) tobacco or any tobacco product. 

(iv) any source material, special nuclear material, or byproduct material 
(as such terms are defined in the Atomic Energy Act of 1954 and regulations 
issued under such Act ) . 

(v) any article which, if sold by the manufacturer, would be subject to the 
tax imposed by section 4181 of the Internal Revenue Code of 1954 (deter- 
mined without regard to any exemptions from such tax provided by section 
4182 or 4221 or any other provision of such Code) , and 

(vi) (A) any substance found in or on any food, drug, cosmetic, or device 
(as such terms are defined in section 201 of the Federal Food, Drug, and 
Cosmetic Act) when manufactured or distributed in commerce for use in 
or any such food, drug, cosmetic, or device, or (B> any substance produced 
for research and development purposes and intended only for use in or on 
any such food. drug, cosmetic, or device. 

The term "food" as used in clause (vi) of this subparagraph includes poultry 
and poultry products (as defined in sections 4(e) and 4(f) of the Poultry 
Products Inspection Act), meat and meat food products (as defined in section 
l(j) of the Federal Meat Inspection Act), and eggs and egg products (as defined 
in section 4 of the Egg Products Inspection Act). 

(3) The term "commerce" means trade, traffic, or transportation (A) between 
a place in a State and any place outside of such State, or (B) which affects such 
trade, traffic or transportation. 

(4) The term "distribute in commerce" or "distribution in commerce" which 
used to describe an action taken with respect to a chemical substance, or the 
introduction or delivery for introduction into commerce of. the substance or 
mixture; or to hold, or the holding of, the substance or mixture after its 
introduction into commerce. 

(5) The term "environment" includes humans and their environment, water, 
atmosphere, and land and the interrelationships which exist among and between 
these. 



79-313 - 77 - 18 



266 



(6) The term "health and safety study" means any study of any effects of a 
chemical substance or mixture on health or the environment, including epide- 
miological studies, studies of occupational exposure to a chemical substance or 
mixture, toxicological, clinical, and ecological studies of a chemical substance 
or mixture, and any test performed pursuant to this Act. 

(7) The term "manufacture" means to import, produce, or manufacture for 
commercial purposes. 

(8) The term "mixture" means any combination of two or more chemical sub- 
stances if such substances (A) do not react chemically with each other and if 
the combination is not the result of a chemical reaction, or (B) occur in nature. 

(9) The term "new chemical substance" means any chemical substance not 
included in the chemical substance list compiled and published under section 
8(b). 

(10) The term "process" means the preparation of a chemical substance or 
mixture for distribution in commerce — 

(A) in the same form or physical state, or in a different form or physical 
state from that in which it was received by the person making such prepara- 
tion, or 

(B) as part of an article containing the chemical substance or mixture. 

(11) The term "processor" means any person who processes a chemical sub- 
stance or mixture. 

(12) The term "standards for the development of test data" means a prescrip- 
tion of — 

(A) the— 

( i ) health and environmental effects, and 

(ii) type of information relating to toxicity, persistence, and other 
characteristics w^hich relate to effects on health and the environment 

for which test data for a chemical substance or mixture are to be developed 
and any analysis that is to be performed on such data, and 

(B) to the extent necessary to assure that such data are reliable and 
adequate, the manner in which such data are to be developed, the specifica- 
tion of any test protocol or methodology to be employed in the development 
of data respecting such effects and characteristics, and such other require- 
ments as are necessary to provide such assurance. 

(13) The term "State" means any of the several States, the District of 
Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, the 
Canal Zone, American Samoa, or the Trust Territory of the Pacific Islands. 

(14) The term "United States", when used in the geographic sense, means all 
the States. 

(15) The term "unreasonable adverse effects on the environment" means any 
unreasonable risk to man or to the environment taking into account the economic, 
social, and environmental costs and benefits of the use of any chemical substance. 

(b) Exclusions. — The Administrator may exclude from coverage of this Act 
or any provision of this Act any chemical substance or mixture if the Admin- 
istrator determines, by rule, that such substance or mixture does not present an 
unreasonable risk of injury to health or the environment, except that any such 
exclusion shall not apply to section 7 or 8(e). Any such rule shall (A) be 
promulgated pursuant to the procedures specified in section 6(c) (2), (3), (4), 
and (5) and (B) may be modified, amended, or revoked in accordance with the 
requirements of this subsection and pursuant to the procedures specified in such 
section 6(c) (2), (3), (4), and (5). 

TESTING OF CHEMICAL SUBSTANCES AND MIXTURES 

Sec. 4. (a) Testing Requirements. — If the Administrator finds that — 

(l)(A)(i) the manufacture, processing, distribution in commerce, use, 
or disposal of a chemical substance or mixture may present an unreasonable 
risk of injury to health or the environment, or (ii) (I) that the manu- 
facture, processing, distribution in commerce, use, or disposal of a chemical 
substance or mixture may present significant human or environmental 
exposure because it is or will be produced in substantial quantities or for 
other reasons, and (II) that such substance or mixture may perhaps pre- 
sent an adverse effect on health or the environment. 

(B) there are insuflicient data or experience upon which the effects of 
such manufacture, processing, distribution in commerce, use, or disposal 
on health or the environment can reasonably be determined or predicted, 
and 



267 



(C) testing of such substance or mixture with respect to such effects is 
necessary to develop such data ; and 

(2) in the case of a mixture, the effects which the mixture's manufacture, 
distribution in commerce, processing, use, or disposal may have on health 
or the environment may not be reasonably and more efficiently determined 
or predicted by testing chemical substances which compromise the mixture : 
the Administrator shall by rule require that testing be conducted on such 
substance or mixture to develop data with respect to the health and environ- 
mental effects for which there is an insufficiency of data or experience and 
which are relevant to a determination that the manufacture, distribution in 
commerce, processing, use, or disposal of such substance or mixture does or 
does not contribute to an unreasonable risk of injury to health or the environ- 
ment. Ill requiring tests under this subsection, the Administrator shall consider 
the reasonably ascertainable costs and other l)urdens associated with conducting 
such tests in light of the possible risks of injurj- to health or the environment 
and shall publish the same in the Federal Register. The finding in paragraph 
( 1) ( A ) ( ii) (II) shall be presumed if the Administrator has no reliable data 
or exj)erience available to him concerning the chemical substance or mi-xture. 
The linding in paragraph (l)(ii)(II) shall not be subject to judicial review 
on any ground other than the fact that such finding was not made. 

(b)(1) Testing Requu!iement Rule. — ,A rule under subsection (a) requiring 
the testing of a chemical substance or mixture shall include — 

(A) identification of the substance or mixture for which testing is 
required. 

(B) standards for the development of test data for such substance or 
mixture, and 

((') with respect to chemical substances which are not new chemical 
substances a specification of the i)eriod (which period may not be of un- 
reasonable duration) within which the persons required to conduct the 
testing shall submit to the Administrator data developed in accordance with 
the standards referred to in subparagraph (B). Such a rule may require the 
submission of preliminary data during the period prescribed under sub- 
paragraph (C). 

(2) (A) The health and environmental effects for which standards for the 
develoi)ment of test data may be prescribed include carcinogenesis, mutagenesis, 
teratogenesis, behavioral disorders, cumulative or synergistic effects, and any 
other effect which may cause or contribute to an unreasonable risk of injury 
to health or the environment, and the characteristics of chemical substances 
and mixtures for which such standards may be prescribed include persistence, 
acute toxicity, .subacute toxicity, chronic toxicity, and any other characteristic 
which may cause or contribute to such a risk of injury. The methodologies that 
may be prescribed in such standards include epidemiology, serial, or hierarchical 
tests : in vitro tests ; and whole animal tests. 

(B) From time to time, but not less than once each 12 months, the Admin- 
istrator shall review the adequacy of tlie standards for development of data 
prescribed in rule.s under subsection (a) and shall, if necessary, institute pro- 
ceedings to make appropriate revisions of such standards. 

(3) (A) A rule under subsection (a) respecting a chemical substance or mix- 
ture sliall require the persons described in subparagraph (B) to conduct tests 
and submit data on such substance or mixture, except that the Administrator 
may permit two or more of such per.sons to designate one such i)erson or a quali- 
fied third party to conduct such tests and submit .such data on behalf of the 
persons making the designation. 

(B) Tlie following persons shall be vcquired to conduct tests and submit data 
on a chemical substance or mixture .subject to a rule under sub.section (a) : 

(i) Each person who manufactures or intends to manufacture such sub- 
stance or mixture if the Administrator made a finding described in sub- 
section (a)(1)(B) with respect to the manufacture of the substance or 
mixture which such person is engaged in or intends to engage in. 

(ii) Each person who processes or intends to process such .substance or 
mixture if the Administrator made a finding described in subsection (a) 
(1) (B) with respect to tlie processing of the substance which such person 
is engaged in or intends to engage in. 

(iii) Each person who manufactures or processes or intends to manu- 
facture or process such substance or mixture if, with respect to the dis- 



268 



tribution in commerce, disposal or use of such substance or mixture manu- 
factured or processed by such person, the Administrator made a finding 
described in subsection (a)Q)(B). 
(4) Rules issued under subsection (a) (and any amendment thereto or repeal 
thereof) shall be promulgated pursuant to section 553 of title 5, United States 
Code, except that in promulgating, amending, or repealing any such rule (A) the 
Administrator shall give interested persons an opportunity for the oral presen- 
tation of data, views, or arguments, in addition to an opportunity to make 
written submissions ; and ( B ) a transcript shall be made of any oral presen- 
tation. 

(c) Exemption. — (1) Any person required l)y a rule under subsection (a) to 
conduct tests and submit data on a chemical substance or mixture may apply 
to the Administrator (in such form and manner as the Administrator shall pre- 
scribe) for an exemption from such requirement. 

(2) If, upon receipt of an application under paragraph (1), the Administrator 
determines that — 

(A) the chemical substance or mixture with respect to which such appli- 
cation was submitted is equivalent to a chemical substance or mixture for 
which data has been submitted to the Administrator in accordance with a 
rule under subsection (a) or for which data is being developed pursuant 
to such a rule, and 

(B) submission of data by the applicant on such substance or mixture 
would be duplicative of data which has been submitted to the Administrator 
in accordance with such rule or w^hich is being developed pursuant to such 
rule. 

the Administrator shall exempt, in accordance with paragraph (3) or (4), the 
applicant from conducting tests and submitting data on such substance or 
mixture. 

(3) (A) If the exemption of any person from the requirement to conduct tests 
and submit test data on a chemical substance or mixture is granted on the 
basis of the existence of previously submitted test data and if such exemption 
is granted during the reimbursement period for such test data (as. prescribed 
by subparagraph (B)), then (unless such i)erson and the persons referred to 
in clauses (i) and (ii) agree on the amount and method of reimbursement) the 
Administrator shall order the person granted the exemption to provide fair and 
equitable reimbursement (in an amount determined under rules of the Admin- 
istrator)^ — 

(i) to the person who previously submitted such test data, for a portion 
of the costs incurred by such person in complying with the requirement to 
submit such data, and 

(ii) to any other person w^ho has been required under this subparagraph 
to contribute with respect to such costs, for a portion of the amount such 
person was required to contribute. 

In promulgating rules for the determination of fair and equitable reimburse- 
ment to the persons described in clauses (i) and (ii) for costs incurred with 
respect to a chemical substance or mixture, the Administrator shall, after con- 
sultation with the Attorney General and the Federal Trade Commission, consider 
all relevant factors, including the effect on competition within the chemical 
industry and the share of the market for such substance or mixture of the 
r)erson required to provide reimbursement in relation to the share of such market 
of the persons to be reimbursed. An order under this subparagraph for purposes 
of judicial review shall be considered final agency action. 

(B) For purposes of subparagraph (A), the reimbursement period for any 
test dat^ for a chemical substance or mixture is a period — 

(i) beginning on the date such data was submitted in accordance with a 
rule promulgated under subsection (a ) , and 

(ii) ending — 

( I ) two years after the date referred to in clause ( i ) , or 

(II) at the expiration of a period which begins on the date referred 
to in clause (i) and is equal to the period w^hich the Administrator 
determines was necessary to develop such data, 

whichever is later. 

(4) (A) If the exemption of any person from the requirement to conduct tests 
and submit test data on a chemical subsatnce or mixture is granted on the basis 
of the fact that test data is being developed by one or more persons pursuant to 



269 



a rule promulgated under subsection (a), then (unless such i>erson and the 
persons referred to in clauses (i) and (ii) agree on the amount and method of 
reinibursem^»nt ) the Administrator shall issue an order to the person granted 
the exemption to provide fair and equitable reimbursement (in an amount 
determined under rules of the Administrator) — 

(ij to each such i)erson who is developing such test data, for a portion of 
the costs incurred by each such person in complying with such rule, and 

(ii) to any other person who has been required under this subparagraph 
to contribute with respect to the costs of complying with such rule, for a 
portion of the amount such i^erson was required to contribute. 
In promulgating rules for the determination of fair and equitable reimbursement 
to the persons described in clauses (i) and (ii) for costs incurred with respect 
to a chemical substance or mixture, the Administrator shall, after consultation 
with the Attorney General and the Federal Trade Commission, consider all 
relevant factors, including the effect on comi)etition within the chemical industry 
and the share of the market for such substance or mixture of the person required 
to provide reimbursement in relation to the share of such market of the persons 
to be reimbursed. An order under this subparagraph for purposes of judicial 
review .sliall l)e considered final agency action. 

(B) If an exemption is granted on the basis of the fact that one or more 
persons are developing test data pur.suant to a rule promulgated under subsec- 
tion (a> and if after such exemption is granted the Administrator determines 
that no such i)erson has complie<l with such rule, the Administrator shall (i) 
after providing written notice to the i>erson who holds sucli exemption and an 
opportunity for a hearing, by order terminate such exemption, and (ii) notify 
in writing such person of the requirements of the rule with respect to which 
such exemption was granted. 

('}) If a y)erson provides reimbursement pursuant to an order issued under 
paragraph (3) (A) or (4) (A) in connection with an exemption from a rule 
promulgated under subsection (a), such person may, subject to section 14, have 
access to test data the submission or development of which was the basis for 
such exemption. 

. (d) Notice. — Uix)n the receipt of any test data pursuant to a rule under sub- 
s-ection (a), the Admini.*<trator shall (subject to section 14) publish a notice of 
the receipt of such data in the Federal Register and make the data available 
to the public within 15 days of receipt. Each such notice shall (1) identify the 
chemical substance or mixture for wliich data have been received; (2) list 
the uses or intended uses of such substance or mixture and the information 
required by the applicable .standards for the development of test data; and (3) 
describe the nature of the test data developed. 

(e) PRTOKITY liTST. — (1) (A) There is establi.shed a committee to make recom- 
mendations to the Administrator resi>ecting the chemical substances and mix- 
tures to which the Administrator should give priority consideration for the 
promulgation of a rule under subsection (a). In making such a determination 
with respect to any chemical substance or mixture, the committee shall consider 
all relevant factors, including — 

(i) the quantities in which the .substance or mixture is or will be 
manufactured, • 

(ii) the quantities in which the .substance or mixture enters or will enter 
the environment, 

(iii) the numl>er of i^ersons who are or will be exposed to the substance 
or mixture in their places of employment and the duration of such exposure, 

(iv) the extent to which humans are or will be exposed to the substance 
or mixture. 

(v) the extent to which the substance or mixture is closely related to a 
chemical substance or mixture which is known to cause or contribute to 
an unreasonable risk to health or the environment. 

(vi) the existence of data concerning the effects of the substance or 
mixture on health or the environment, and 

(vii) the extent to which testing of the substance or mixture may result 
in the development of data upon which the effects of the substance or 
mixture on health or the environment can reasonably be determined or 
predicted. 

The recommendations of the committee shall be in the form of a list of chemical 
substances and mixtures which shall be listed, either by individual substance or 



270 



mixture or by groups of substances or mixtures, in the order in which the com- 
mittee determines the Administrator should take action under subsection (a) 
with respect to the substances and mixtures. The committee shall jrive priority 
attention in establishing such list to those chemical substances and mixtures 
which are known or are suspected of causing or contributing to (i) cancer, (ii) 
gene mutations, or (iii) birth defects. 

(B) As soon as practicable but not later than nine months after the date of the 
enactment of this Act, the committee shall publish in the Federal Register the 
list required by subparagraph (A) together with the reasons for the committee's 
inclusion of each chemical substance or mixture on the list. At least every 6 
months after the publication of the list pursuant to the preceding sentence, the 
committee shall make such revisions in the list as it determines to be necessary 
and shall publish the list in the Federal Register with tbe committee's revisions 
(if any) and the reasons for the revisions. Within the 12-month period beginning 
on the date of the inclusion of a chemical substance or mixture on such a list the 
Administrator shall with respect to such chemical substance or mixture either 
(i) initiate a rulemaking proceeding under section 4(a) or (ii) if such a pro- 
ceeding is not initiated within such period, publish in the Federal Register the 
Administrator's reasons for not initiating such a proceeding. 

(C) The Administrator may promulgate a rule under subsection (a) with re- 
spect to a chemical substance or mixture (i) which is not contained on a list 
published under this subsection or (ii) whether or the Administrator has pub- 
lished in the Federal Register reasons for not initiating a proceeding under sub- 
paragraph (B). 

(2) (A) The committee established by paragraph (1) (A) shall consist of 
seven members as follows : 

(i) One member (or designee of the member) appointed from the Depart- 
ment of Commerce by the Secretary. 

(ii) One member (or designee of the member) appointed from the En- 
vironmental Protection Agency by the Administrate". 

(iii) One member (or designee of the member) appointed by the Secretary 
of Labor from officers of the Department of Labor engaged in the Secretary's 
activities under the Occupational Safety and Health Act of 1970. 

(iv) One member (or designee of the member) appointed from the Coun- 
cil on Environmental Quality by the Chairman of the Council. 

(v) One member Cor designee of the member) appointed from the Na- 
tional Institute for Occupational Safety and Health by the Director of the 
Institute. 

(vi) One member (or the designee of the member) appointed from the 
National Institute of Environmental Health Sciences by the Director of the 
Institute. 

(vii) One member (or designee of the member) appointed from the Na- 
tional Cancer Institute by the Director of the Institute. 

(viii) One member (or designee of the member) appointed from the Na- 
tional Science Foundation by the Director of the Foundation. 

A member may designate an individual to serve on the member's behalf only 
with the approval of the applicable appointing authority and only if the indi- 
vidual is from the entity from which the member was appointed. A vacancy in 
the committee shall be filled in the same manner in which the original appoint- 
ment was made. 

(B) (i) The term of office of a member of the committee is 4 years, except that 
of the members first appointed, four members shall have initial terms of 2 years. 
Any member appointed to fill a vacancy occurring prior to tiie expiration of the 
term for which the member's predecessor was appointed shall be appointed only 
for the remainder of such term. If any member of the commirtee leaves the office 
or entity from which the member was appointed, such member's term of office 
shall be terminated and the member's position shall be considered as being va- 
cant. A member may serve after the expiration of tbe member's term of office 
until a successor has taken office. Members may lie reappointed. 

(ii) Initial appointments to the committee shall be made not later than the 
60th day after the date of the enactment of this Act. Not later than the OOth day 
after such date of enactment the members of the committee shall hold a meeting 
for the selection of a chairman from among their number and to determine, by 
lot, the four members who shall have initial terms of 2 years. 

(C) (i) No member of the committee, or designee of such member, shall accept 
employment or compensation from any person subject to any requirement of this 



271 



Act. or rules issued thereunder, for a period of at least 24 months after termina- 
tion of employment with such agency. 

(ii) No person, while serving as a member of such committee, or designee of 
such member, may own any stocks or bonds, or have any pecuniary interest in 
any firm, association, or corporation engaged in the manufacture, processing, or 
distribution of ^ny chemical substance or mixture subject to the provisions of 
this Act. 

(iii) The Administrator or the Attorney General bring an action in the appro- 
priate district court of the United States to restrain any violations of this 
subparagraph. 

(D) The Administrator shall provide the committee such administrative and 
staff support services as may be necessary for the committee to carry out its 
functions under this subsection. 

(f ) Required Actions. — (1) Upon the receipt of (A) any test data required to 
be submitted under this section or under section o. or (B) any other information 
available to the Administrator which indicates that a chemical .substance or mix- 
ture has the potential, at levels for which human exposure exists or may exist 
and with appropriate safety margins, to induce in human beings (1 ) cancer. (2) 
gene mutations, or (3) birth defects, the Administrator shall take appropriate 
action under section 5(e), 6(a). or 7, within 180 days after the receipt of such 
data or information to limit exposure of human beings with respect to such sub- 
stance or mixture, or he shall publish in the Federal Register his findings that 
no unreasonable risk of injury is i)resented and rea.sons therefor. Any such find- 
ing under this subsection that nounreasonable ri.sk is presented shall be review- 
able in accordance with chapter 7 of title 5. United States Code. 

(2) Nothing contained in this subsection shall require the Administrator to 
take action under section Hfe). 6(a). or 7, or publish his reasons for failing to 
take such action, until 2 years after the date of enactment of this Act. 

PREMARKET NOTIFICATION OF CHEMICAL SUBSTANCES 

Sec. 5. (a) General. — (1) Commencing 1 year and 30 days after the date of 
enactment of this Act, a manufacturer shall notify the Administrator, who shall 
notify the public as required in subsection (c). of any planned manufacture of a 
new chemical substance, at least 90 days prior to the commencement of such 
manufacture. Such notice to the Administrator shall be accompanied by all 
pertinent information referred to in section 8(a)(2), whether or not the Ad- 
ministrator has required the submission thereof under section 8(a)(2), except 
that with respect to the information referred to under section 8(a) (2) (E), such 
manufacturer may submit a description of such information, as defined by the 
Administrator, by rule. 

(2) The Administrator shall give priority attention to a chemical substance 
with respect to which information is received indicating that serious economic 
or other hardships are likely to result if there is any delay in manufacture. If 
the Administrator finds that such a substance does not present an unreasonable 
risk to human health and the environment, he may reduce the number of days, 
after submission of such information, during which manufacture may not occur. 
The Administrator shall promptly publish (subject to .section 14) his findings and 
the basis therefor in the Federal Register. 

(b) Submission of Data. — Any manufacturer of a new chemical substance 
that is covered by section 4(a) shall submit to the Administrator (in addition to 
the information required in subsection (a) the data developed in accordance 
with such requirement at least 90 days prior to such manufacture, and the 
Administrator shall make it publicly available in accordance with subsection (c). 

(c) Data Availability. — "Within 15 days after receipt, the Administrator shall 
promptly publish in the Federal Register (subject to section 14) the identity of 
each chemical substance for which a notice has been received under subsection 
(a) or (b). the intended use or distribution of such substance, and a statement 
that the data and other information is available. The 90 days referred to in sub- 
sections (a) and (b) shall begin upon publication under this sub.section in the 
Federal Register. 

(d) Extension. — The Administrator may extend, for an additional period 
beyond the 90-day period referred to in subsection (a) or (b). the date after 
which a new chemical substance may be manufactured. Such additional period 
may not exceed 90 days and shall not be imposed except for good cause .shown. 
Notice of any such extension, and the reasons therefor, shall be published (sub- 



272 



ject to section 14) in the Federal Register. Such an extension shall constitute a 
final action for purposes of judicial review. 

(e) Orders. — (1) (A) If the Administrator finds, during the 90-day period 
referred to insubsection (a) or (b) or during any extension thereof, with 
resi^ect to any new chemical substance for which notification is required under 
this section — 

(i) that such new chemical substance is covered by a test requirement 
under section 4(a), but that such requirement requires additions or re- 
visions with respect to such substance ; or 

(ii) that such new^ chemical substance is not covered by such a require- 
ment under section 4(a), but that such requirement should be established; 
he shall issue an order in accordance with this subsection. Such an order 
shall appropriately prohibit or restrict the manufacture, processing, distri- 
bution in commerce, use, or disposal of such new chemical substance pend- 
ing the completion of a rulemaking proceeding under section 4(a) and the 
submission of any data required thereunder, as described under subpara- 
graph (B) ; shall contain a proposed rule under section 4(a) ; and shall be 
immediately effective. 

(B) Upon the issuance of any order under subparagraph (A), the Adminis- 
trator shall proceed with a rulemaking procedure as expeditiously as practicable 
under section 4(a) and in accordance with subparagraph (C). During the course 
of, or upon the completion of, such rulemaking, the Administrator shall, if neces- 
sary, appropriately modify or rescind any order issued under subparagraph (A). 
If any testing requirements are established as a result of such rulemaking, any 
provision of such order restricting the manufacture, processing, distribution in 
commerce, use, or disposal of such substance shall remain in effect, unless modi- 
fied or rescinded, pending the submission of such data to the Administrator and 
the completion of procedures described in subsection (b) or any extension 
imposed under subsection (d). 

(C) If the Administrator issues an order under subparagraph (A), the Ad- 
ministrator shall provide interested persons reasonable opportunity, in accord- 
ance with section 4(b) (4) to make presentations and submissions mth respect 
to such order. If such presentation or submission is requested, the Administrator 
shall comply within 30 days from the date such request is made unless the 
Administrator and the person making the request agree upon a later date. 
Within 10 days after such presentations and submission are concluded, the 
Administrator shall consider such presentations and submissions and aflirm, 
modify, or revoke such order. 

(2) (A) If the Administrator finds, during the 90-day period referred to in 
subsection (a) or (b) or during any extension thereof, with respect to any new 
chemical substance for which notification is required under this section, that a 
rule is appropriate under section 6(a). he shall issue an order in accordance 
with this subsection. Such an order shall appropriately prescribe such require- 
ments as are authorized under section 6(a) : shall contain a proposed rule under 
section 6(a) ; and shall be immediately effective. 

(B) Upon the issuance of any order under subparagraph (A), the Adminis- 
trator shall proceed with a rulemaking procedure as expeditiously as practicable 
under section 6(a) and in accordance with subparagraph (C). During the course 
of, or upon the completion of such rulemaking, the Administrator shall, if neces- 
sary, appropriately modify or rescind any order issued under subparagraph (A). 

(C) If the Administrator issues an order under subparagraph (A), the Ad- 
ministrator shall provide interested persons reasonable oi)portunity, in accord- 
ance with section 6(c) (2) and (3) for an informal hearing with respect to such 
order. If such hearing is requested, the Administrator shall comply within 30 
days from the date such request is made unless the Administrator and the per- 
son making the request agree upon a later date. Within 10 days after such hear- 
ing is concluded, the Administrator shall consider the information presented at 
such hearing and aflBrm, modify, or revoke such order. 

(f ) Statement of Reasons for Not Taking Action. — Prior to the expiration 
of 90 days after the date of publication under subsection (c), of data and infor- 
mation with respect to a new chemical substance, or prior to the expiration of 
such i)eriod as extended under subsection (d), the Administrator shall publish 
a statement of his reasons in the Federal Register, if he decides not to take 
action under subsection (e) or section 7 with respect to such chemical substance 
during such period. Manufacture may commence following publication of the 



273 



Administrator's statement. The Administrator's failure to issue such an order 
under subsection (e) or take action under section 7 is an action subject to 
judicial review in accordance with section 19. Nothing in this subsection pro- 
hibits the Administrator from — 

(1) promulgating a rule pursuant to section 6 or 4, with respect to such 
a substance, after such manufacture has commenced ; 

(2) taking action against any chemical substance which is found to be an 
imminent hazard pursuant to section 7 ; or 

(3) taking any other action authorized by this Act. 

(g) Exemption. — (1) The Administrator may upon application (made in such 
form and manner as the Administrator may prescribe) exempt any i)erson from 
the requirement of subsection (b) or (h) to submit data for a chemical sub- 
stance or mixture. If, upon receipt of an application under the preceding sen- 
tence, the Administrator determines that — 

(A) the chemical substance or mixture with resi)ect to which such ap- 
plication was submitted is equivalent to a chemical substance or mixture 
for which data has been submitted to the Administrator in accordance with 
subsection (b) or (h), and 

(B) submission of data by the applicant with respect to such substance 
would be duplicative of data which has been submitted to the Administrator 
in accordance with such subsection, 

the Administrator shall exempt the applicant from submitting such data with 
respect to such substance. No exemption granted under this subparagraph with 
respect to the submission of data for a chemical substance or mixture may take 
effect before the beginning of the reimbursement period applicable to such data. 

(2) If the Administrator, under paragraph (1), exempts any i>erson from sub- 
mitting under subsection (b) or (h) data for a chemical substance or mixture 
because of the existence of previously submitted data and if such exemption is 
granted during the reimbursement period for such data, then (unless such per- 
son and the T)ersons referred to in subparagraphs (A) and (B) agree on the 
amount and method of reimbursement) the Administrator shall order the i^erson 
granted the exemption to provide fair and equitable reimbursement (in an 
amount determined under the rules of the Administrator) — 

(A) to the person who previously submitted the data on which the ex- 
emption was based, for a portion of the costs incurred by such person in 
complying with the requirement under subse<*tion (b) or (h) to submit 
such data, and 

(B) to any other person who has been required under this subparagraph 
to contribute with respect to such costs, for a portion of the amount such 
person was required to contribute. 

In promulgating rules for the determination of fair and equitable reimbursement 
to the persons described in subparagraphs (A) and (B) for costs incurred with 
respect to a chemical substance or mixture, the Administrator shall, after con- 
sulting with the Attorney General and the Federal Trade Commission, consider 
all relevant factors, including the effect on c.omx)etiti()n within the chemical 
industry and the share of the market for such substance or mixture of the person 
required to provide reimbursement in relation to the share of such market of the 
persons to be reimbursed. An order under this subparagraph shall be considered 
final agency action, for purposes of judicial review. 

(3) For puri)Oses of this paragraph, the reimbursement period for any 
previously submitted data for a chemical substance or mixture is a period — 

(A) beginning on the date of the termination of the prohibition, imposed 
under this section, on the manufacture or processing of such substance by 
the person who submitted such data to the Administrator, and 

(B) ending — 

(i) two years after the date referred to in subparagraph (A), or 

(ii) at the expiration of a period which begins on the date referred 
to in subparagraph (A) and is equal to the period which the Adminis- 
trator determines was necessary to develop such data, 

whichever is later. 

(h) Significant New Use. — (1) Within months after the date of enact- 
ment of this Act, and from time to time thereafter, tlie Administrator shall, by 
rule, estabHsh criteria defining a significant new distribution in commerce, 
use, or disposal of a chemical substance. In establishing such criteria the Ad- 
ministrator shall take into account — 

(A) projected volume of production ; 



274 



( B ) projected category or categories of uses ; 

(C) projected increase in magnitude and duration of human and en- 
vironmental exposure ; 

(D) route or routes of exposure of human beings or of the environment 
that are attributable to such significant new use : and 

( E ) the human health and environmental effects thereof. 

(2) A chemical substance may not be manufactured or processed for a dis- 
tribution in commerce use, or disposal that is identified by the Administrator, 
in a rule, as a significant new distribution in commerce, use, or disposal, unless, 
at least 90 days prior to such manufacture or processing, the i^erson intending 
to manufacture or process such substance for such distribution in commerce, 
use, or disposal submits a notice of his intention to do so and any data required 
to be develoi>ed under section 4(a) to the Administrator. Any such use of such 
substance shall be subject to all of the provisions of this section. 

(i) Special Exemption, — The Administrator may, upon application and by 
rule, exempt any person from the foregoing requirements of this section — 

(1) for the purpose of permitting such person to manufacture, process, 
distribute in commerce, use, or dispose of a new chemical substance to which 
a rule under section (a) is applicable for test marketing purposes or 
specially limited purposes (A) upon a showing by such person that such 
activity will not cause or contribute to an imreasonable risk of injury to 
human health or the environment, and (B) under such restrictions as the 
Administrator considers appropriate ; or 

(2) to the extent that such person manufactures chemical substances 
which are intermediate reaction products formed during the manufacture 
of other chemical substances and for which there is no exposure to human 
beings or the environment. 

(j) MixTiTtES. — The Administrator is authorized to specify any mixture 
which shall be subject to the provisions of this section. 

(k) Experimentation. — The requirements of subsections (a), (b), and (h) 
do not apply to any chemical substance which is manufactured or intended to 
be manufactured only in small quantities (as defined by the Administrator by 
rule) solely for scientific experimentation or analysis or for chemical research 
or analysis, including such research or analysis for the development of a prod- 
uct, except that the Administrator may, by rule, include such chemical sub- 
stances upon a finding that the manufacture, processing, distribution in 
commerce, use, or disposal of such chemical substances may cause or contribute to 
an unreasonable risk of injury to human health or the environment. 

REGULATION OF CHEMICAL SUBSTANCES AND MIXTURES 

Sec. 6. (a) Scope of Regulation. — (1) If the Administrator finds that the 
manufacture, processing, distribution in commerce, use, or disposal of a chemical 
substance or mixture presents or is likely to present an unreasonable risk of 
injury to health or the environment, the Administrator shall by rule apply to 
such substance or mixture one or more of the following requirements as is 
necessary to adequately protect against such risk using the least burdensome of 
effective controls : 

(A) A requirement prohibiting processing or distribution in commerce of 
such substance or mixture or limiting the amount of such substance or mixture 
which may be manufactured, processed, or distributed in commerce. 

(B) A requirement — 

(I) prohibiting the manufacture, processing or distribution in commerce 
of such substance or mixture for (i) a particular use or particular uses or 
(ii) a particular use or particular uses in a concentration in excess of a 
level specified by the Administrator in the rule imposing the requirement, 
or 

(II) limiting the amount of such substance or mixture which may be 
manufactured, processed, or distributed in commerce for (i) a particular 
use or particular uses or (ii) a particular use or particula uses in a con- 
concentration in excess of a level specified by the Administrator in the rule 
imposing the requirement. 

(C) A requirement regulating the manner or method of use or disposal of 
such substance or mixture. 

(D) A requirement that such substance or mixture or any article containing 
such substance or mixture be marked with or accompanied by clear and adequate 



275 



warnings and instructions with respect to its distribution in commerce, use, or 
disposal. The form and content of such warnings and instructions shall be pre- 
scribed by the Administrator. 

(E) A requirement directing manufacturers or processors of such substance 
or mixture (i) to give notice of such unreasonable risk of injury to distributors 
in commerce of such .substance or mixture and, to the extent reasonably ascer- 
tainable, to other i^rsons in possession of such substance or mixture or exposed 
to such substance or mixture, (ii) to give public notice of such risk of injury, 
and (iii) to either replace or repurchase such substance or mixture whichever 
the pers(m to which the requirement is directed elects. 

(F) A requirement that manufacturers and processors of such substance or 
mixture make and retain records of the processes used to manufacture or proc- 
ess such substance or mixture and monitor or conduct tests which are reason- 
able and necessary to assure compliance with the requirements of this subsection. 
A requirement imi)Osed under this subsection may be limited in application to 
specified geographic areas. 

(2) Rules limiting the amount of a chemical substance or mixture which 
may be manufactured, processed, or distributed in conmierce, or limiting, the 
amount of such substance which may be manufactured, processed, or dis- 
tribute<l for a particular use shall, upon the i)etition of any manufacturer, proc- 
essor, or distributor in commerce thereof, provide for assigning production, 
processing, and distribution quotas, to the extent necessary with respect to the 
chemical substance involved. The i)ermi.ssible quota for each person who ap- 
plies to manufacture, process, or import such substance or to engage in its 
distribution in commerce shall be determined in accordance with fair and equit- 
able criteria which the Secretary of Coinmerce. in consultation with the Ad- 
ministrator and the Attorney General, shall prescribe by rule. Such criteria 
shall take into account all relevant factors, including ( A ) effects on competition ; 
(B) the market shares, productive capacity and product and raw material in- 
ventories of the precursors of the chemical substance or mixture of persons 
applying for quotas : (C) emergency conditions : and (D) effects on technological 
innovation. 

(3) (A) Prior to the issuance of a quota under paragraph (2) the persons who 
apply under such paragraph shall attempt to develop a voluntary agreement 
limiting the quantities which each such person .shall manufacture, process, im- 
port, or distribute. The availability of immunity from the antitrust laws with 
respect to the development of such voluntary agreement shall be limited to the 
provisions of this subsection. 

(B) The Secretary of Commerce, with the approval of the Attorney General, 
after each of them has consulted with the Federal Trade Commission, shall pre- 
scribe, by rule, .standards and procedures by which persons .seeking to manu- 
facture, process, import, or other\\ise distribute a chemical substance or mixture 
for which limitations on quantity have been prescribed pursuant to paragraph 
(B)(II) of subsection (a) of this section may develop and carry out such 
voluntary agreements as are permissible pursuant to this subsection. 

(C) The standards and pnx^dures prescribed under subi>aragraph (A) shall 
include the following requirements : 

(i) Meetings held to develop or carry out a voluntary agreement under this 
subsection shall permit attendanc-e by repre.sentatives of Committees of Con- 
gress and interested i)ersons. including all i>ersons interested in the chemical 
substance or mixture involved, and the public : shall be preceded by timely and 
adequate notice with identification of the agenda of such meeting to the Secre- 
tary of Commerce, the Attorney General, the P>deral Trade Commission, the 
Administrator and the public; and .shall be chaired by a regular full-time Federal 
employee. 

(ii) A full and complete record, and where practicable a verbatim trans- 
cript, shall be kept of any meeting held, and a full and complete record shall be 
kept of any communication (other than in a meeting) made, between or among 
participants or potential participants, to develop, or carry out a voluntary 
agreement under this subsection. Such record or transcript shall be deposited, 
together with any agreement resulting therefrom, with the Secretary of Com- 
merce and the Administrator and shall be available to the Attoney General and 
the Federal Trade Commission. Such records or transcripts shall be available 
for public inspection and copying in accordance with section 552 of title 5, United 
States Code. 



276 



(D) (i) The Attorney General and the Federal Trade Commission shall par- 
ticipate from the beginning in the development, and when practicable, in the 
carrying out of voluntary agreements and plans of action authorized under this 
section. Each may propose any alternative which would void or overcome, to 
the greatest extent practicable, possible anticompetitive effects while achieving 
substantially the purpose of this subsection. A voluntary agreement under this 
subsection may not be carried out unless approved by the Attorney General, 
after consultation with the Federal Trade Commission. Prior to the expiration 
of the 20-day period prescribed under clause ( ii ) , the Federal Trade Commission 
shall transmit to the Attorney General its views as to whether such an agree- 
ment or plan of action should be approved, and shall publish such views in the 
Federal Register. The Attorney General, in consultation with the Federal Trade 
Commission, and the Secretary, shall have the right to review, amend, modify, 
disapprove, or revoke, on his own motion or upon the request of the Federal 
Trade Commission or any interested i)erson, any voluntary agreement at any 
time, and, if revoked, thereby withdraw prospectively any immunity which may 
be conferred by subparagraphs ( F ) or ( 1 ) . 

(ii) Any voluntary agreement entered into pursuant to this section shall be 
submitted in writing to the Attorney General and the Federal Trade Commis- 
sion 20 days before being implemented. Any such agreement shall be available for 
public inspection and copying, to the extent to which records or transcripts are so 
available as provided in the last sentence of subparagraph (C) (ii). Any action 
taken pursuant to such voluntary agreement or plan of action shall be reported 
to the Attorney General and the Federal Trade Commission pursuant to such 
regulations as shall be prescribed under clauses (iii) and (iv) of subparagraph 
(E). 

(E) (i) The Attorney General and the Federal Trade Commission shall 
monitor the development and carrying out of voluntary agreements authorized 
under this paragraph in order to promote competition and to prevent anticom- 
petitive practices and effects. 

(ii) In addition to any requirement specified under subparagraphs (B) and 
(C) of this paragraph and in order to carry out the purposes of this section, 
the Attorney General, in consultation with the Federal Trade Comnaission and 
the Administrator, shall promulgate rules concerning the maintenance of neces- 
sary and appropriate records related to the development and carrying out of 
voluntary agreements authorized pursuant to this section. 

(iii) Persons developing or carrying out voluntary agreements authorized 
pursuant to this section shall maintain such records as are required by rules 
promulgated under subparagraph (B). The Attorney General and the Federal 
Trade Commission shall have access to and the right to copy such records at 
reasonable times and upon reasonable notice. 

(iv) The Attorney General and the Federal Trade Commission may each pre- 
scribe such rules as may be necessary or appropriate to carry out their respective 
responsibilities under this section. They may both utilize for such purposes and 
for purposes of enforcement any powers conferred upon the Federal Trade Com- 
mission or the Department of Justice, or both, by the antitrust laws or the Anti- 
trust Civil Process Act ; and wherever any such law refers to "the puriyoses of 
this Act" or like terms, the reference shall be understood to include this 
subsection. 

(F) (i) There shall be available as a defense to any civil or criminal action 
brought under the antitrust laws (or any similar State law) in respect to actions 
taken to develop or carry out a voluntary agreement by persons engaged in the 
business of manufacturing, processing, or distributing such chemical substance 
or mixture (provided that such actions were not taken for the purpose of in- 
juring competition) that — 

(I) such actions were taken in the course of developing a voluntary agree- 
ment pursuant to this paragraph to carry out a voluntary agreement author- 
ized and approved in accordance with this section, and 

(II) such persons complied with the requirements of this paragraph and 
the rules promulgated hereunder. 

(ii) Persons interposing the defense provided by this paragraph shall have 
the burden of proof, except that the burden shall be on the person against whom 
the defense is asserted with respect to whether the actions were taken for the 
purpose of injuring competition. . 

(G) No provision of this section shall be construed as granting immunity for, 
or as limiting or in any way affecting any remedy or penalty which may result 



277 



from any legal action or proceeding arising from, any act or practice which 
occurred prior to the date of enactment of this Act or subsequent to its expira- 
tion or repeal.. 

(H) The Attorney General and the Federal Trade Commission shall each sub- 
mit to the Congress and to the President, at least once each year a report on the 
impact on competition and on small business of actions authorized by this 
section. 

(I) In any action in any Federal or State court for breach of contract, there 
shall be available as a defense that the alleged breach of contract was caused 
predominantly by action taken to carry out a voluntary agreement authorized 
and approved in accordance with this paragraph. 

(J) As used in this paragraph, the term "antitrust laws" includes — 

(i) the Act entitled "An Act to protect trade and commerce against un- 
lawful restraints and monopolies", approved July 2, 1890 ; 

(ii) the Act entitled "An Act to supplement existing laws against unlaw- 
ful restraints and monopolies, and for other purposes", approved October 
15, 1914 ; 

(iii) the Federal Trade Commission Act ; 

(iv) section 73 and 74 of the Act entitled "An Act to reduce taxation, to 
provide revenue for the Government, and for other purposes", approved 
August 27, 1894 : and 

(v) the Act of June 19, 1936. chapter 592. 

(b) Quality Control. — (1) If the Administrator has good cause to believe 
that a particular manufacturer or processor is manufacturing or processing a 
chemical substance or mixture in a manner which causes the adulteration of a 
chemical substance or mixture — 

(A) the Administrator may by order require such manufacturer or proc- 
essor to submit a description of the relevant quality ond control procedures 
followed in the manufacturing or processing of such chemical substance or 
mixture ; and 

(B) if the Administrator thereafter determines on the record, after op- 
portunity for hearing in accordance with section 554 of title 5, Ignited States 

. Code, that such quality control procedures are inadequate to prevent the 
chemical substance or mixture from causing or contributing to such risk, the 
Administrator may order the manufacturer or processor to revise such 
quality control procedures to the extent necessary to remedy such 
inadequacy. 

(2) As used in this section, a chemical substance or mixture is adulterated if 
the manner in which it is manufactured or processed causes it to contain a par- 
ticular molecular identity, an uncombined radical, an element, or any combina- 
tion thereof, which is found by the Administrator to cause or contribute to an un- 
reasonable risk of injury to human health or the environment. 

(c) Promutxjation of Subsection (a) Rules. — (1) In promulgating any rule 
under sub.section (a) with respect to a chemical substance or mixture, the Ad- 
ministrator shall consider relevant factors and make findings with respect 
thereto, including — 

(A) the risks presented by .such substance or mixture to health and the 
magnitude of human exi>osure to such substance or mixture. 

(B) the risks presented by such substance or mixture to the environment 
and the magnitude of environmental exposure to such substance or mixture. 

(C) the benefits of such substance or mixture for such use or uses and the 
availability of other substances or mixtures for such use or uses, and 

(D) the reasonably ascertainable economic consequences of the rule, in- 
cluding consideration of the effect on the national economy, innovation, the 
environment, and public health. 

Findings made under this paragraph shall be published in the Federal Register. 

(2) When prescribing a rule under subsection (a) the Administrator shall 
proceed in accordance with section 553 of title 5, United States Code (without 
regard to any reference in such section to sections 556 and 557 of such title), 
and shall also (A) publish a notice of propo.sed rulemaking stating with par- 
ticularity the reason for the proposed rule: (B) allow interested persons to sub- 
mit written data, views, and arguments, and make all such submissions publicly 
available; (C) provide an opportunity for an informal hearing in accordance 
with paragraph (3) : and (D) promulgate, if appropriate, a final rule based on 
the matter in the rulemaking record. 



278 



(3) The Administrator shall conduct informal hearings required by paragraph 
(2) (C) of this subsection in accordance with the following procedure: 

(A) Subject to paragraph (B) of this paragraph, an interested person 
is entitled — 

(i) to present his position orally or by documentary submissions (or 
both ) , and 

(ii) if the Administrator determines that there are disputed issues of 
material fact it is necessary to resolve, to present such rebuttal submis- 
sions and to conduct (or have conducted under subparagraph (B)(ii)) 
such cross-examination of persons as the Administrator determines (I) to 
be appropriate, and (II) to be required for a full and true disclosure with 
respect to such issues. 

(B) The Administrator may prescribe such rules and make such rulings con- 
cerning proceedings in such hearings to avoid unnecessary costs or delay. Such 
rules or rulings may include (i) imposition of reasonable time limits on each in- 
terested person's oral presentations, and (ii) requirements that any cross-ex- 
amination to which a person may be entitled under subparagraph (A) be con- 
ducted by the Administrator on behalf of that person in such manner as the 
Administrator determines (I) to be appropriate, and (II) to be required for a 
full and true disclosure with respect to disputed issues of material fact. 

(C) (i) Except as provided in clause (ii), if a group of persons each of whom 
under subparagraphs (A) and (B) would be entitled to conduct (or have con- 
ducted) cross-examination and who are determined by the Administrator to have 
the same or similar interests in the proceeding cannot agree upon a single repre- 
sentative of such interests for purposes of cross-examination, the Administrator 
may make rules and rulings (I) limiting the representation of such interest for 
such purposes, and (II) governing the manner in which such cross-examination 
shall be limited. 

(ii) When any person who is a member of a group with respect to which the 
Administrator has made a determination under clause (i) is unable to agree 
upon group representation with the other members of the group, then such per- 
son shall not be denied under the authority of clause (i) the opportunity to con- 
duct (or have conducted) cross-examination as to issues affecting his particular 
interests if (I) he satisfies the Administrator that he has made a reasonable and 
good faith effort to reach agreement upon group representation with the other 
members of the group and (II) the Administrator determines that there are 
substantial and relevant issues which are not adequately presented by the group 
representative. 

(D) A verbatim transcript shall be taken of any oral presentation, and cross- 
examination, in informal hearings under this subsection. Such transcript shall 
be available to the public. 

(E) A substantive amendment to, or repeal of, a rule promulgated under 
subsection (a) shall be prescribed, and subject to judicial review, in the same 
manner as a rule prescribed under such subsection. 

(4) Any rule promulgated under this section shall be judicially reviewable in 
accordance with section 19, except that in addition to any basis for holding un- 
lawful or setting aside the rule under subparagraphs (A), (B), (C), or (D) of 
section 706(2) of title 5. United States Code, the court shall hold unlawful and 
shall set aside the rule if the court finds that — 

(A) the Administrator's determination under paragraph (3) that the 
petitioner is not entitled to conduct cross-examination or make rebuttal sub- 
missions, or 

(B) the Administrator's rule or ruling under paragraph (3) limiting the 
petitioner's cross-examination or rebuttal submissions, has precluded dis- 
closure of disputed material facts which was necessary for fair determina- 
tion by the Administrator of the rulemaking proceeding taken as a whole. 

(5) (A) The Administrator may pursuant to rules prescribed by him, provide 
compensation for reasonable attorneys fees, expert witness fees, and other costs 
of participating in a rulemaking proceeding under this section to any person 
(i) who has. or represents an interest (I) which would not otherwise be ade- 
quatelv represented in such proceeding and (II) representation of which is nec- 
essarv" for a fair determination of the rulemaking proceeding taken as a whole, 
or (ii) who is unable effectivelv to participate in such proceeding because such 
person cannot afford to pay costs of making oral presentations, conducting cross- 
examination, and making rebuttal submission in .such proceeding. 

(B) The aggregate amount of compensation paid to all persons in any fiscal 
year under this subsection may not exceed $1,(X)0,000. 



279 



(d) Effective Date. — (1) The Administrator shall specify in any rule under 
'•section (a) the date on which it shall take effect, which date shall be as 

11 as feasible. 

(2) Section 553(b) (B) of title 5, United States Code, shall be applicable to 
rules issued under subsection (a) notwithstanding any requirement of subsec- 
tion (c) (2) or (3) in those situations where compliance with the requirements 
of subsection (c) (2) or (3) would present an unreasonable risk of death, 
serious or substantial personal injury (including illness) or serious or substan- 
tial environmental harm. 

(e) PcLYCHLORiNATED BiPHENYLs. — (1) Effective 1 year after the date of en- 
actment of this Act, it shall be unlawful to manufacture, process distribute in 
commerce, or use any polychlorinated biphenyl in any manner other than in a 
totally enclosed manner, except that the Administrator may, by rule promul- 
gated in accordance with subsection (c) (2), authorize the manufacture, proc- 
essing, distribution in commerce, or use of any polychlorinated biphenyl in other 
than a totally enclosed manner if the Administrator finds that no unreasonable 
risk of injury to health or the environment is presented. 

( 2) Effective 2 years after the date of enactment of this Act, it shall be unlaw- 
ful to manufacture any polychlorinated biphenyl, and effective 2i/^ years after 
such date, it shall be unlawful to process or distribute in commerce any poly- 
chlorinated biphenyl, except that the Administrator may authorize, by rule pro- 
mulgated in accordance with subsection (c)(2), such manufacture, processing, 
or distribution in commerce after such time period if the Administrator finds 
that no imreasonable risk of injury to health or the environment is presented. 

(3) Within 6 months after the date of enactment of this Act, the Administra- 
tor shall promulgate rules under subsection (a) which shall (A) prescribe 
methods for the disposal of polychlorinated biphenyls in accordance with the 
requirements of that subsection and (B) specify the manner in which polychlo- 
rinated biphenyls shall be marked with clear and adequate warnings and in- 
structions with respect to their processing, distribution in commerce, use, or 
disposal. Any such rules shall be consistent with the requirements of paragraphs 
(1 ) and (2) of this subsection or rules issued thereunder. 

(4) For the purposes of this subsection, the term "totally enclosed manner" 
means any manner which will ensure that any leakage of a polychlorinated bi- 

I phenyl from its enclosure will be insignificant, as defined in rules of the 
! Administrator. 

i IMMINENT HAZARDS 

I Sec 7. (a) Definition. — An imminent hazard .shall be considered to exist when 
I the evidence is suflficient to show that a situation exists in which the continued 
I use of a chemical substance would be likely to result in unreasonable adverse 
) effects on the environment or will involve an unreasonable hazard to the sur- 
vival of a species declaired endangered by the Secretary of the Interior under 
Public Law 91-135. 

(b) Actions Authorized.— The Administrator may file an action in a United 
States district court — 

(1) against an imminently hazardous chemical substance or mixture for 
seizure of such substance or mixture, 

(2) against any person who manufactureres. processes, distributes in 
commerce, uses, or disposes of such substance or mixture, or 

(3) against both (A) such substance or mixture and (B) such person. 
An action under this subsection may be filed notwithstanding the existence of 

1 a rule under section 4(a) or 6(a) or an order under section 5(e) and notwith- 
I standing the pendency of any administrative or judicial proceeding under any 
provision of this Act. 

(c) Jfrisdiction of Court. — (1) The T'uited States district court in which 
I an action under subsection (b) is brought shall have jurisdiction to grant such 

temporary or permanent relief as may be nece.ssary to protect against such 
unreansonable risk of death, serious illness or serious personal injury, or 
serious environmental harm presented by the chemical substance or mixture 
involved in such action. 

(2) In the case of an action under subsection (b) brought against a person 
who manufactures, processes, distributes in commerce, uses, or disposes of a 
chemical substance or mixture, the relief authorized by paragraph (1) may 
include the issuance of a mandatory order requiring (A) in the case of pur- 
chasers of such substance or mixture known to the defendant, notification to 
such purchasers of the ri.sk associated with it; (B) public notice of such risk: 



280 



(C) recall; and (D) the replacement or repurchase of such substance or mixture. 

(3) In the case of an action under subsection (b) against a chemical sub- 
stance or mixture, such substance or mixture may be proceeded against by 
process of libel for its seizure and condemnation. Proceedings in such an action 
shall conform as nearly as possible to proceedings in rem in admiralty. 

(d) Venue and Consolidation. — (1)(A) An action under subsection (b) 
against a person who manufactures, processes, distributes in commerce, uses, 
or disposes of a chemical substance or mixture may be brought in the United 
States District Court for the District of Columbia or for any judicial district 
in which any of the defendants is found, resides, or transacts business ; and 
process in such an action may be served on a defendant in any district in which 
such defendant resides or may be found. An action under subsection (b) against 
a chemical substance or mixture may be brought in any United States district 
court within the jurisdiction of which the substance or mixture is found. 

(B) In determining the judicial district in which an action may be brought 
under subsection (b) in instances in which such action may be brought in more 
than one judicial district, the Administrator shall take into account the con- 
venience of the parties. 

(C) Subpoenas requiring attendance of witnesses in an action brought under 
subsection (b) may run into any judicial district. 

(2) Whenever proceedings under subsection (b) involving the same type of 
chemical substances or mixtures are pending in courts in two or more judicial 
districts, they shall be consolidated for trial by order of any such court upon 
application reasonably made by any party in interest, upon notice to all parties 
in interest. 

(e) Action Under Section 6. — Where appropriate, concurrently with the 
filing of an action under subsection (b) or as soon thereafter as may be practi- 
cable, the Administrator shall initiate a proceeding for the promulgation of a 
rule under section 6(a). 

(f) Representation. — Notmthstanding any other provision of law, in any 
action under subsection (b), the Administrator may direct attorneys of the En- 
vironmental Protection Agency to appear and represent the Administrator in 
such an action. 

reporting and retention of information 

Sec. 8. (a) Reports. — (1) The Administrator shall promulgate rules under 
which — 

(A) each person who maanufactures or processes or proposes to manu- 
facture or process a chemical substance shall maintain such records, and 
shall submit to the Administrator such reports, as the Administrator may 
reasonably require, and 

(B) each person who manufactures or processes or proposes to manu- 
facture or process — 

(i) a mixture, or 

(ii) a chemical substance in small quantities (as defined by the Ad- 
ministrator by rule) solely for scientific experimentation or analysis 
or for chemical research or analy.sis. including such research or analysis 
for the development of a product, shall maintain records and submit to 
the Administrator reports but only to the extent the Administrator 
determines the maintenance of records or submission of reports, or both, 
is necessary for the effective enforcement of the Act. For purposes of 
the compilation of the list of chemical substances required under sub- 
section (b), the Administrator shall promulgate rules pursuant to this 
subsection not later than 180 days after the date of the enactment of 
this Act. 

(2) The Administrator may require under paragraph (1) reporting with 
respect to the following : 

(A) The common name, trade name, the chemical identity, and the molecular 
structure and identity of each chemical ."substance or mixture for which such a 
report is required, insofar as known to the person making the report or insofar 
as reasonably ascertainable. 

(B) The categories or proposed categories of use of each such substance or 
mixture, insofar as known to the person making the report or insofar as reason- 
ably ascertainable. 

(C) Reas^onable estimates of the amount of each substance and mixture to be 
manufactured or processed and. insofar as known to the per.son making the 



281 



report or insofar as reasonably ascertainable, a reasonable estimate of the 
amount of each such substance and mixture to be manufactured or processed 
for each of its categories or proposed categories of use. 

( D ) A description of the byproducts resulting from the manufacture, process- 
ing, use, or disposal of each such substance or mixture, insofar as known to the 
person making the report or insofar as reasonably ascertainable. 

(E) All existing data concerning the environmental and health effects of such 
substance or mixture, insofar as known to the person making the report or are 
reasonably ascertainable. 

( F) Estimates of the number of persons who will be exi)osed to such substance 
or mixture in their places of employment and the duration of such exposure, 
insofar as known to the person making the report or are reasonably 
ascertainable. 

(b) Inventory. — The Administrator shall compile, keep current, and publish 
a list of each chemical substance or mixture which any person reports under 
subsection (a) or under section 5(a) is manufactured or processed in the United 
States. The Administrator shall first publish such a list not later than 270 days 
after the date of enactment of this Act. The Administrator shall not include 
in such list any chemical substance which is manufactured or processed only in 
small quantities (as defined by the Administrator by rule) solely for scientific 
experimentation or analysis or for chemical research or analysis, including such 
research or analysis for the development of a product. 

(c) Records. — Any person who manufactures, processes, or distributes in com- 
merce or intends to manufacture, process, or distribute in commerce any chemical 
substance or mixture shall maintain records of adverse reactions to health or the 
environment alleged to have been caused by the substance or mixture. Recoi*ds 
of such adverse reactions to the health of employees shall be retained for 30 
years from the date such reactions were first reported to or known by the 
person maintaining such records; and any other record of such adverse reactions 
shall be retained for 5 years from the date the information contained in the 
records was first reported to or known by the person maintaining the records. 
Records under this subsection shall include records of consumer allegations 
of personal injury or harm to health, reports of occupational disease or injury, 
arid reports or complaints of injury to the environment submitted to the manu- 
facturer, processor, or distributor in commerce from any source. Upon request of 
an officer or employee duly designated by the Administrator, each person who is 
required to maintain records under this subsection shall permit the inspection 
of such records and shall submit copies of such records. 

(d) Health axd Safety Studies. — The Administrator shall promulgate rules 
under which the Administrator requires any person who manufactures, processes, 
or distributes in commerce or who proposes to manufacture, process, or distribute 
in commerce any chemical substance or mixture to submit to the Administrator — 

(1) lists of health and safety studies conducted or initiated by or for such 
person with respect to such substance or mixture at any time or known 
to such rx'rson or are reasonably ascertainable, except that the Administra- 
tor may exclude certain types or categories of studies from the require- 
ments of this subsection if he finds that submission of lists of such studies 
are unneces.sary. to carry out the purposes of this Act; and 

(2) the Administrator may require the submission of any study contained 
on a list otherwise known by such person. 

(e) Notice to Administrator of T'nreasonable Risks. — Any i)erson who 
manufactures, processes, or distributes in commerce a chemical substance or 
mixture, and any liability insurer of such person, who obtains information which 
supports the conclusion that such su])stance or mixture causes or contributes 
to an unreasonable risk of injury to health or the environment shall imme- 
diately inform the Administrator of such risk unless such person has reason 
to believe that the Administrator has been adequately informed of such risk. 

relationship to other federal laws 

Sec. (a) Lam's Not Administered by the Administrator. — (1) If the 
Administrator has reason to believe that the manufacture, processing, distribu- 
tion in commerce, use. or disposal of a chemical substance or mixture causes or 
contributes to. or is likely to cause or contribute to an unreasonable risk 
of injury to health or the environment, and determines, in his discretion, that 
such risk may be prevented or reduced to a sufficient extent by action taken under 



79-313 - 77 - 19 



282 



a Federal law not administered by the Administrator, the Administrator shall 
request the agency which administers such law (A) to issue an order declar- 
ing whether or not the manufacture, processing, distribution in commerce, use, 
or disposal of such substance or mixture causes or contributes to or is likely 
to cause or contribute to such a risk, and (B) if the agency issues an order 
declaring that such manufacture, processing, distribution in commerce, use, 
or disposal respecting such substance or mixture causes or contributes to or 
is likely to cause or contribute to such a risk, to determine if such risk miay 
be prevented or reduced to a sufficient extent by action taken under such law. 
Any such request shall be published in the Federal Register and shall be 
accompanied by a detailed statement of the information on which it is based. 
The agency receiving the request shall consider carefully all data submitted 
by the Administrator and other information available to it and shall issue 
an appropriate order upon request, and shall make any resulting determination 
within such reasonable time as the Administrator specifies in the request, but 
such time specified may not be less than 90 days from the date the request was 
made. The report of an agency in response to a request made under this i>ara- 
graph shall be accompanied by a detailed statement of the findings and con- 
clusions of the agency respecting the order and determination requested to be 
made. 

(2) If the Administrator makes a request under paragraph (1) with respect 
to a chemical substance or mixture and the agency to which such request was 
made either — 

(A) issues an order declaring that there is no unreasonable risk of injury 
to health or the environment associated with such substance or mixture, or 

(B) initiates, within 90 days of the publication in the Federal Register of 
the report of the agency under paragraph (1) in response to such request, 
action under the law (or laws) administered by such agency to protect 
against such a risk, 

the Administrator may not take any action under section 6 or 7 with respect 
to the risk associated with such substance or mixture. Nothing contained herein 
shall prevent the Administrator from (A) making any subsequent request under 
paragraph (1) with respect to such risks or (B) to take subsequent action under 
this Act with respect to such risks if the requirements of this ^bsection are 
satisfied. 

(3) If the Administrator has initiated laction under section 6 or 7 with 
respect to a risk of injury associated with a chemical substance or mixture 
which was the subject of a request made to an agency under paragraph (1), such 
agency shall before taking action under the law (or laws) administered by 
it to protect against such risk consult with the Administrator for the pmpose of 
avoiding duplication of Federal action against such risk. 

(b) Laws Administered by the Administrator. — The Administrator shall 
coordinate actions taken under this Act with actions taken under other Federal 
laws administered in whole or in part by the Administrator. The Administrator 
shall use the authorities contained in such other Federal laws to protect against 
any risk to health or the environment associated with a chemical substance or 
mixture unless the Administrator, in his discretion, determines that such risk 
may be more appropriately protected ac-ainst under this Act. This subsection 
shall not be construed to relieve the Administrator of any requirement imposed 
on the Administrator by such other Federal laws. Nothing contained in this 
subsection shall (1) aifect any final action taken under such other Federal law, 
or (2) in any way affect the extent to which human health or the environment 
is to be< protected under such other Federal law. 

(c) OccTTPATioNAL SAFETY AND HEALTH. — In cxcrcisiug any authority under 
this Act. the Administrator shall not, for purposes of section 4(b) (1) of the 
Occupational Safety and Henlth Act of 1970. be deemed to be exercising statutory 
authority to prescribe or enforce standards or regulations affecting occupational 
safety and health. 

(d) Coordination. — In administering this Act. the Administrator shall con- 
sult and coordinate with the Secretarv of Health. Education, and Welfare and 
the heads of any other appropriate Federal executive department or agency, 
any relevant independent regulatory agency, and any other appropriate intsru- 
mentalitv of the Federal Oovernment for the purpose of achieving the maxi- 
mum enforcement of this Act while imposing the least burdens of duplicative 
requirements on those subjects to the Act and for other purposes. The adminis- 



283 



I trator shall report annually to the Congre^ on actions taken to coordinate with 
I such other Federal departments, agencies, or instrumentalities, and on actions 

taken to coordinate the authority under this Act with the authority granted 

under other Acts referred to in su])section (b). 

(e) Exception. — Nothing contained in this section shall limit any require- 
I ment of section 4, 5 (other than section 5(e)(2)), or 8, or rules promulgated 

thereunder. 

RESEARCH. COLLECTION. DISSEMINATION, AND UTILIZATION OF DATA 

Sec. 10. (a) Authority. — The Administrators shall, in consultation and co- 
operation with the Secretary of Health, p:ducation. and Welfare and with other 
heads of appropriate agencies, conduct such research and monitoring as is 
necessary to carry out the purposes of this Act. In accordance with such 
respon.^ihilities. the Administrator shall undertake and support programs of re- 
search and monitoring of iM)lychlorinated biphenyls to the extent neces.sary to 
develop safe methods of disiK)sal of polychlorinated l)iphenyls and for the con- 
trol of risks of injury to health or the environment associated with polychlo- 
rinated biphenyls. 

(b) Data Systems. — ) The Administrator shall establish, administer, and be 
responsible for the continuing activities of an interagency committee which will 
(A) design, establish, and coordinate an efficient and effective sy.stem, within the 
Environmental I'rotection Agency, for the collection, dissemination to other 
Federal agencies, and u.<<e of data submitted to the Administrator under this Act 
and (B) coordinate the regulation of chemical substances among Federal 
agencies. 

(2) (A) The Administrator shall, in consultation with the Secretary of Health, 
Education, and Welfare and other heads of appropriate agencies, design, estab- 
lish, and coordinate an efficient and effective system for the retrieval of toxi- 
cological and other .scientific data which could be useful to the Administrator in 
carrying out the purposes of this Act. Systematized retrieval shall be developed 
for u.se by all Federal and other agencies with responsibilities in the area of 
regulation or study of chemical substances and mixtures and their effect on 
health, or the environment. 

(c) Grants and Contracts. — The Administrator, in consultation with the 
Secretary of Health. Education, and Welfare, is authorized to make grants and 
enter into contracts in order to carry out his responsibilities under this section. 
Contracts may be entered into under this section without regard to sections 3648 
and 3709 of the Revised Statutes (31 U.S.C. 529, 41 U.S.C. 5). 

INSPECTIONS AND SUBPOENAS 

Sec. 11. (a) Inspections. — (1) For puri>oses of administering this Act (in- 
cluding any rule or order promulgated under this Act) the Administrator, or any 
representative of the Administrator duly designated by the Administrator, may 
insi^ect any establishment, facility, or other premises in which chemical sub- 
stances or mixtures are manufactured, proce.ssed. stored, or held before or after 
distribution in commerce and any conveyance l>eing u.^ed to transport chemical 
substances or mixtures in connection with distribution in commerce. Such an 
in.spection may only be made uimui presenting appropriate credentials and a writ- 
ten notice to the owner, operator, or agent in charge of the premi.ses or convey- 
ance to be inspected. A separate notice shall be given for each such inspection, 
but a notice shall not l)e required for each entry made during the period covered 
by the inspection. Each such inspection shall be commenced and completed with 
reasonable promptness and shall be conducted at reasonable times, within rea- 
sonable limits, and in a reasonable manner. 

(2) An inspection under paragraph (1) shall extend to all things within the 
premises or conveyance insi>ected (including records, files, papers, processes, con- 
troLs. and facilities) bearing on whether the requirements of this Act applica- 
ble to the chemical sul)stances or mixtures within such premises or conveyance 
have been complied with. 

(b) Subpoenas. — In carrying out his or her duties under the provisions of this 
Act, the Administrator may by subpoena require the attendance and testimony of 
witnesses and the production of reports, papers, documents, answers to questions, 
or other information that the Administrator deems advisable. Witnesses shall 
be paid the same fees and mileage that are paid witnes.ses in the courts of the 



284 



United ' states. In the event of contumacy, failure, or refusal of any person to 
obey any such order, any district court of the United States in which venue is 
proper shall have jurisdicion to order any such person to comply therewith. The 
failure to obey such order of the Court is punishable by the Court as a contempt 
thereof. 

EXPORT 

Sec. 12. (a) General. — (1) Except as provided in paragraph (2) and subsec- 
tion (b), this Act (other than section 8) shall not apply to any chemical sub- 
stance or mixture, if — 

(A) it can be shown that such substance or mixture is being manufactured, 
processed, sold, or held for sale, for export from the United States, unless 
such substances or mixture is, in fact, manufactured, processed, or distrib- 
uted in commerce, for use in the United States, and 

(B) such substance or mixture, when distributed in commerce, or any 
container in which it is enclosed when so distributed, bears a stamp or label 
stating that such substance or mixture, is intended for export. 

(2) Paragraph (1) shall not apply to any chemical substance or mixture if the 
Administrator finds that the substance or mixture will cause or contribute to 
an unreasonable risk of injury to the health of persons within the United States 
or to the environment of the United States or may cause or contribute to such 
risk. The Administrator may require, under section 4, testing of a chemical 
substance or mixture exempted from this Act by paragraph (1) to determine 
whether or not such substance or mixture causes or contributes to an unreason- 
able risk to health within the United States or to the environment of the United 
States. 

(b) Notice. — (1) If any person exports or intends to export to a foreign 
country a chemical substance or mixture for which the submission of data is 
required under section 4 or 5, such person shall notify the Administrator of 
such exportation or intent to export and the Administrator shall furnish to the 
government of such country notice of the availability of the data (subject to 
section 14) submitted to the Administrator under section 4 or 5 for such sub- 
stance or mixture. 

(2) If any person exports or intends to export to a foreign country a chemical 
substance or mixture for which a rule has been proposed or promijlgated under 
section 5 or 6, or with respect to which an action is pending, or relief has been 
granted, under section 7, such person shall notify the Administrator of such 
exportation or intent to export and the Administrator shall furnish to the gov- 
ernment of such country notice of such rule, action, or relief. 

ENTRY INTO CUSTOMS TERRITORY OF THE UNITED STATES 

Sec. 13. (a) General. — (1) The Secretary of the Treasury shall refuse entry 
into the customs territory of the United States (as defined in general headnote 2 
of the Tariff Schedules of the United States) of any chemical substance or mix- 
ture offered for entry if — 

(A) it fails to conform with any requirement of this Act or any rule in 
effect thereunder, or 

(B) it is otherwise prohibited pursuant to this Act from being distributed 
in commerce. 

(2) If a chemical substance or mixture is refused entry under paragraph (1), 
the Secretary of the Treasury shall notify the consignee of such entry refusal, 
shall not release it to the consignee, and shall cause its disposal or storage (under 
such regulations as the Secretary of the Treasury may prescribe) if it has not 
been exported by the consignee within 90 days from the date of receipt of notice 
of such refusal, except that the Secretary of the Treasury may, pending a review 
by the Administrator of the entry refusal, release to the consignee such sub- 
stance or mixture on execution of bond for the amount of the full invoice of 
such substance or mixture (as such value is set forth in the customs entry), 
together with the duty thereon. On failure to return such substance or mixture 
for any cause to the custody of the Secretary of the Treasury when demanded, 
such consignee shall be liable to the United States for liquidated damages equal 
to the full amount of such bond. All charges for storage, cartage, and labor on 
such substances or mixtures which are refused entry or release under this sec- 
tion shall be paid by the owner or consignee, and in default of such payment 
shall constitute a lien against any future entry made by such owner or con- 



285 



signee. Nothing contained herein shall limit any other remedy to which the United 
States is entitled. 

(b) Rules. — The Secretary of the Treasury, after consultation with the 
Administrator, shall issue rules for the enforcement of subsection (a) of this 
section. 

DISCLOSURE OF DATA 

Sec. 14. Any information reported to, or otherwise obtained by, the Adminis- 
trator or his representatives, under this Act, shall be subject to section 552 of 
title 5, United States Code; except that such information shall be disclosed — 

(1) upon request, to officers or employees of the United States, in connec- 
tion with their official duties (A) under laws protecting human health or the 
environment or (B) for specific law enforc-ement purposes; 

(2) to contractors with the United States and employees of such con- 
tractors if in the opinion of the Administrator such disclosure is necessary 
for the satisfactory performance by the contractor of a contract with the 
United States entered into on or after the date of enactment of this Act for 
the performance of work in connection with this Act and under such condi- 
tions as the Administrator may specify ; 

(3) whenever the Administrator determines it necessary to protect human 
health or the environment ; or 

(4) to any duly authorized committee of the Congress upon written re- 
quest of such commitee or any chairman thereof. 

PROHIBITED ACTS 

Sec. 15. It shall be unlawful for any person to — 

(1) fail or refuse to comply with (A) any rule or order promulgated under 
section 4, (B) any requirement prescribed by section 5 or 6, or (C) any rule 
or order promulgated under section 5 or 6 ; 

(2) use or dispose of a chemical substance or mixture which such person 
knew or had reason to know was manufactured, processed, or distributed 
in commerce in violation of section 5 or a rule or order under section 6 ; 

(3) fail or refuse to (A) establishor maintain records, (B) submit reports, 
notices, or other information, or (C) permit access to or copying of records, as 
required by this Act or a rule thereunder; or 

(4) fail or refuse to permit entry or inspection as required by section 11. 

PENALTIES 

Sec. 10. (a) Civil. — (1) Any person who violates a provision of section 15 of 
this Act shall be liable to the United States for a civil penalty in an amount not 
to exceed $25,000 for each such violation. Each day such a violation continues 
shall for purposes of this subsection constitute a separate violation of section 15. 

(2) (A) A civil i>enalty for a violation of section 15 shall l)e assessed by the 
Administrator by an order made on the record after opi>ortunity (provided in 
accordance with this subparagraph) for a hearing in accordance with section 554 
of title 5, United States Code. Before issuing such an order, the Administrator 
shall give written notice to the person to be assessed a civil penalty under such 
order of the Administrator's proposal to issue such order and providing such 
person an opportunity to re<iuest, within 15 days of the date the notice is received 
by such person, such a hearing on the order. 

(B) In determining the amount of a civil penalty, the Administrator shall take 
into account the nature, circumstances, extent, and gravity of the violation or 
violations and, with respect to the violator, ability to pay, effect on ability to con- 
tinue to do business, any history of prior such violations, the degree of culpa- 
bility, and such other matters as justice may require. 

(C) The Administrator may compromise, modify, or remit, with or without 
conditions, any civil penalty which may be imposed under this subsection. The 
amount of such penalty, when finally determined, or the amount agreed upon in 
compromise, may be deducted from any sums owed by the United States to the 
person charged. 

(3) Any person who requested in accordance with paragraph (2) (A) a hearing 
respecting the assessment of a civil penalty and who is aggrieved by an order 
assessing a civil penalty may file a petition for judicial review of such order 
with the United States Court of Appeals for the District of Columbia Circuit or 
for any other circuit in which such person resides or transacts business. Such a 



286 



petition may only be filed within the 30-day period beginning on the date the 
order making such assessment was issued. 

(4) If any person fails to pay an assessment of a civil i)enalty after it has 
become a final and unappealable order, or after a court in an action brought 
under paragraph (3) has entered final judgment in favor of the Administrator, 
the Attorney General shall recover the amount assessed (plus interest at cur- 
rently prevailing rates from such date) in any appropriate United States district 
court. In such action, the validity, amount, and appropriateness of such penalty 
shall not be subject to review. 

(b) Criminal.— (1) Any person who knowingly or willfully violates any 
provision of section 15 shall, in addition to or in lieu of a civil penalty which may 
be imposed under subsection (a) of this section for such violation, be subject 
upon conviction, to a fine of not more than $25,000 for each day of violation, or 
to imprisonment for not more than 1 year, or both. 

(2) For purposes of paragraph (1), the term "knowingly" means having actual 
knowledge. 

SPECIAL ENFORCEMENT AND SEIZURE 

Sec. 17. (a) Specific Enforcement. — (1) Upon application of the Adminis- 
trator or the Attorney General the United States district courts shall have juris- 
diction over civil actions to — 

(A) restrain any violation of section 15, 

(B) restraint any person from manufacturing or processing a chemical 
substance before the expiration of the period during which such manufac- 
turing or processing is i>rohibited under section 5, 

(C) restrain any person from taking any action prohibited by a require- 
ment prescribed under section 5 or 6 or rules or orders issued thereunder or, 

(D) direct any manufacturer or a chemical substance or mixture not in 
compliance with any order issued under section 5(e) or any rule issued under 
section 4 or 6, (i) to give notice of such fact to distributors in commerce of 
such substance or mixture and, to the extent reasonably ascertainable, to 
other persons in possession of such substance or mixture or exposed to such 
substance or mixture, (ii) to give public notice of such risk of injury, and 
(iii) to either replace or repurchase such substance or mixtu?fe whichever 
the person to which the requirement is directed elects. 

(E) compel the taking of any action required by or under this Act. 
(2) A civil action described in paragraph (1) may be brought — 

(A) in the case of a civil action described in subparagraph (A) of such 
paragraph, in the United States district court for the judicial district wherein 
any act, omission, or transaction constituting a violation of section 15 oc- 
curred or wherein the defendant is found or transacts business, or 

(B) in the case of any other civil action described in such paragraph, in 
the United States district court for the judicial district wherein the de- 
fendant is found or transacts business. 

In any civil action process may be served on a defendant in any judicial district 
in which a defendant resides or may be found. Subpoenas requiring attendance of 
witnesses in any such action may run into any judicial district. 

(b) Seizure. — Any chemical substance or mixture which was manufactured, 
processed, or distributed in commerce in violation of this Act or any rule or order 
promulgated under this Act shall be liable to be proceeded against, by process of 
libel for the seizure and condemnation of such substance or mixture in any United 
States district court within the jurisdiction of which such substance or mixture 
is found. Such proceedings shall conform as nearly as possible to proceedings in 
rem in admiralty. 

pre-emption 

Sec. 18. (a) Effect on State Law. — (1) Except as provided in paragraph (2), 
nothing in this Act shall affect the authority of any State or political subdivision 
of a State to establish or continue in effect regulation of any chemical substance 
or mixture containing a chemical substance or mixture. 
(2) Except as provided in subsection (b) — 

(A) if the Administrator requires by rule promulgated under section 4 the 
testing of a chemical substance or mixture, no State or political subdivision 
may, after the effective date of such rule, require the testing of such substance 



287 



or mixture for purposes similar to those for which testing is required under 

^"(6^!? 'the'^\dministrator prescribes a requirement under section 5 or 6 
of this let whlch^s applicable to a chemical substance or mixture and which 
's de gted^o protect against a risk to health or the envm>nment associated 
with such substance or mixture no State or political subdivision of a State 
may after me eff^tive date of such requirement, establish or contmue in 
effect a requirement applicable to such substance or mixture and designed to 
protect aXst such risk unless such requirement is identical to tbe require- 
ment prescribed by the Administrator or unless such State or political sub- 
div?sioirrequi?ement prohibits the use or distribution of such substance or 
mixture w?thin the territorial jurisdiction of the State or pohtical sub- 

(b? ExEMPTioN.-Upon application of a State or political subdivision of a 
State, the Administrator may by rule exempt such State or subdivision from 
subse<>tion (a) (2), under such conditions as may be prescribed in such rule, if— 
"(1) compliance with the requirement would not cause the substance or 
mixture to be in violation of the applicable under this Act described in 
subsection (a) (2), and . c-^ifi 

C^) the State or pohtical subdivision requirement (A) provides a signifi- 
cantly higher degree of protection from such risk than the requirement under 
this Act described in subsection (a) (2), and (B) does not, through difficul- 
ties in marketing, distribution, or other factors, unduly burden interstate 
commerce. 

JUDICIAL REVIEW 

Sec. 19. (a) General.— Not later than GO days following the promulgation of 
any rule under this Act or an order under section 5(e), any interested person may 
file a i)etition for judicial review of such rule or order with the United States 
Court of Appeals for the District of Columbia Circuit, or for the circuit in which 
such person resides or in wliich such i)erson's principal place of business is 
located. Copies of the i>etition shall be forthwith transmitted by the clerk of 
such court to the Administrator and to the Attorney General. The Administrator 
shall transmit to the Attorney General, wlio shall tile in the court, the record 
of the proceedings on which the Administrator based such rule or order as 
provided in section 2112 of title 28, United States Code. For purposes of this 
section, the term "record" means such rule or order, any transcript required of 
any oral presentation ; any written submission of interested parties ; and any 
other information which the Administrator, (m or before the date of the promul- 
gation of such rule or order, published a notice in the Federal Register identify- 
ing such information. 

(b) Additional Data. — If the petitioner applies to the court for leave to 
adduce additional data, views, or arguments, and shows to the satisfaction of 
the court that such additional data, views, or arguments are material and that 
there are reasonable grounds for the i)etitioner\s failure to adduce such data, 
views, or arguments in the proceeding before the Administrator, the court may 
order the Administrator to provide additional opportunity for oral presentation 
of data, views, or arguments and for written submissions. The Administrator 
may modify findings or determinations upon which the rule or order, subject to 
review by such court was based, or make new findings or determinations by rea- 
son of the additional data, views, or arguments so taken and shall file such 
modified or new findings or determinations, and the Administrator's recommenda- 
tion, if any, for the modification or setting aside of such rule or order, with the 
return of such additional data, views, or arguments. 

(c) Authority and Review Standard. — (1) Upon the filing of a petition under 
subsection (a), the court shall have jurisdiction (A) to review the rule or order 
involved in accordance with chapter 7 of title 5, United States Code, and (B) 
to grant appropriate relief, including interim relief, as provided in such chapter, 
except that any rule promulgated by the Administrator under section 3(b), 5, 
or 6 of this Act and reviewed under this section shall be affirmed, unless the rule 
is not supported by substantial evidence on the record taken as a whole. 

(2) The judgment of the court affirming or setting aside, in whole or in part, 
any rule or order reviewed in accordance with this section shall be final, subject to 
review by the Supreme Court of the United States upon certiorari or certification, 
as provided in section 12'54 of title 28, the United States Code. 



288 



(3) The judgment of the court in an action brought pursuant to subsection (a) 
mav include an award of costs of suit and reasonable fees for attorneys and ex- 
pert witnesses if the court determines that such an award is appropriate. The bu- 
preme Court of the United States in its decision on a review of a judgment in 
such an action mav provide for the award of costs in suit and reasonable fees for 
attornevs if the court determines that such an award is appropriate. 

(d) Other Remedies.— The remedies provided in this section shall be in addi- 
tion to and not in lieu of any other remedies provided by law. 

citizen's civil action 

Sec. 20. (a) In General.— Except as provided in subsection (b), any person 
may commence a civil action — 

(1) against any person (including (A) the United States, and (B) any 
other governmental instrumentality or agency to the extent permitted by 
the eleventh amendment to the Constitution) who is alleged to be in violation 
of this Act or any rule or order prescribed under section 4, 5, or 6(a) to re- 
strain such violation, or 

(2) against the Administrator to compel the Administrator to perform any 
act or duty under this Act which is not discretionary. 

Any civil action under i>aragraph (1) shall be brought in the district court of 
the' United States for the district in which the alleged violation occurred or in 
which the defendant resides or in which the defendant's principal place of busi- 
ness is located. Any action brought under paragraph (2) shall be brought in the 
district court for the District of Columbia, or the United States district court for 
the judicial district in which the plainiff is domiciled. The district courts shall 
have jurisdiction over suits brought under this section, without regard to the 
amount in controversy or the citizenship of the parties. In any civil action under 
this subsection, process may be served on a defendant in any judicial district in 
which the defendant resides or may be found and subpoenas for witnesses may 
run into any judicial district. 

(b) Limitation. — No civil action may be commenced — 

(1) under subsection (a)(1) to restrain a violation of this Act or rule or 
order under this Act — 

(A) before the expiration of sixty days after the plaintiff has given 
notice of such violation (i) to the Administrator, and (ii) to the person 
who is alleged to have committed such violation, or 

(B) if the Administrator (or Attorney General on his behalf) has 
commenced and is diligently prosecuting a civil action in a court of the 
United States to require compliance with this Act of such rule, but if 
such action is commenced after the giving of notice, any person giving 
such notice may intervene as a matter of right in such action ; or 

(2) under subsection (a)(2) before the expiration of 60 days after the 
plaintiff has given notice to the Administrator of the alleged failure of the 
Administrator to perform an act or duty which is the basis for such action 
or, in the case of an action under such subsection for the failure of the Ad- 
ministrator to file an action under section 7, before the expiration of 10 days 
after such notification. 

Notice under this subsection shall be given in such manner as the Administrator 
shall prescribe by rule. 

(c) General. — (1) In any action under this section, the Administrator, if not 
a party, may interv ene as a matter of right. 

(2) The court, in issuing any final order in any action brought pursuant to 
subsection (a), may award costs of suit and reasonable fees for attorneys and 
expert witnesses if the court determines that such an award is appropriate. 
Any court, in issuing its decision in an action brought to review such an order, 
may award costs of suit and reasonable fees for attorneys if the court deter- 
mines that such an award is appropriate. 

(3) Nothing in this section shall restrict any right which any person (or 
class of persons) may have under any statute or common law to seek enforce- 
ment of this Act or any rule under this Act or to seek any other relief. 

(d) Consolidation. — When two or more civil actions brought under subsec- 
tion (a) involving the same defendant or plaintiffs and the same issues or viola- 
tions are pending in two or more judicial districts, such pending actions, upon 



289 



application of such defendant or plaintiff to such actions which is made to a 
court in its discretion so decides, be consolidated for trial by order (issued 
after giving all parties reasonable notice and opportunity to be heard) of such 
court and tried in — 

(1) any district which is selected by such defendant or plaintiff and in 
which one of such actions is pending. 

(2) a district which is agreed upon by stipulation between all the parties 
to such actions and in which one of such actions is pending, or 

(3) a district which is selected by the court and in which one of such 
actions is pending. 

The court issuing such an order shall give prompt notification of the order to 
the other courts in which the civil actions consolidated under the order are 
pending. 

citizens' petitions 

Sec. 21. (a) Ix General. — Any person may petition the Administrator to 
issue a rule or order, or to take other action under this Act, the purpose of 
which is to protect against an unreasonable risk of injury to health or the 
environment. 

(b) Procedures. — (1) Such petition shall be filed in the principal office of 
the Administrator and shall set forth the facts which it is claimed establish 
that such rule, order or other action is necessary. 

(2) The Administrator may hold a public hearing or may conduct such 
investigation or proceeding as the Administrator deems appropriate in order to 
determine whether or not such petition should be granted. 

(3) Within 90 days after filing of a petition described in paragraph (1), the 
Administrator shall either grant or deny the petition. If the Administrator 
grants such petition, the Administrator shall promptly commence an appropriate 
proceeding to comply with such petition. If the Administrator denies such 
petition, the Administrator shall publish in the Federal Register the Adminis- 
trator's reasons for such denial. 

(4) (A) If the Administrator denies a petition filed under this section (or if 
the Administrator fails to grant or deny such petition within the 90-day period), 
the petitioner may commence a civil action in a United States district court to 
compel the Administrator to initiate the action requested. Any such action shall 
be filed within 60 days after the Administrator's denial of the petition or, if 
the Administrator fails to grant or deny the petition within 90 days after filing 
the petition, within GO days after the expiration of the 90-day period. 

(B) If the petitioner can demonstrate to the satisfaction of the court, by a 
preponderance of the evidence in a de novo proceeding before such court, that 
the action requested in the petition conforms to the applicable requirements 
of this Act, the court shall order the Administrator to initiate the action requested 
by the petitioner. 

(C) The court in issuing any final order in any action brought pursuant to 
subparagraph (A), may award costs of suit and reasonable fees for attorneys 
and expert witnesses if the court determines that such an award is appropriate. 
Any court, in issuing its decision in an action brought to review such an order, 
may award costs of suit and reasonable fees for attorneys if the court deter- 
mines that such an award is appropriate. 

(5) The remedies under this section shall be in addition to, and not in lieu 
of, other remedies provided by law. 

NATIONAL DEFENSE WAI\T:R 

Sec. 22. The Administrator shall waive compliance with any provision of this 
Act upon request of the Secretary of Defense and upon a determination by the 
President that the requested waiver is necessary in the interest of national 
defense. The Administrator shall maintain a written record of the basis upon 
which such waiver was granted and make such record available for in camera 
examination when relevant in a judicial proceeding under this Act. Upon the 
issuance of such a waiver, the Administrator shall publish in the Federal 
Register a notice that the waiver was granted for national defense purposes, 
unless, upon the request of the Secretary of Defense, the Administrator deter- 
mines to omit such publication because the publication itself would be contrary 
to the interests of national defense, in which event the Administrator shall 
submit notice thereof to the Armed Services Committees of the Senate and the 
House of Representatives. 



290 



EMPLOYEE PROTECTION 

Sec. 23. (a) General. — No employer may discharge any employee or otherwise 
discriminate against any employee with respect to the employee's compensation, 
terms, conditions, or privileges of employment because the employee (or any 
person acting pursuant to a request of the employee) has — 

( 1 ) commenced, caused to be commenced, or is about to commence or cause 
to be commenced a proceeding under this Act; 

(2) testified or is about to testify in any such proceeding; or 

(3) assisted or participated or is about to assist or participate in any 
manner in such a proceeding or in any other action to carry out the puri)oses 
of this Act. 

(b) Remedy. — (1) Any employee who believes that he or she has been dis- 
charged or otherwise discriminated against by any person in violation of sub- 
section (a) of this section may, within 30 days after such alleged violation 
occurs, file (or have any person file on the employee's behalf) a complaint with 
the Secretary of Labor (hereinafter in this section referred to as the "Secre- 
tary") alleging such discharge or discrimination. Upon receipt of such a com- 
plaint, the Secretary shall notify the person named in the complaint of the 
filing of the complaint. 

(2) (A) Upon receipt of a complaint filed under paragraph (1), the Secretary 
shall conduct an investigation of the violation alleged in the complaint. Within 
30 days of the receipt of such complaint, the Secretary shall complete such 
investigation and shall notify in writing the complainant (and any i)erson 
acting on behalf of the complainant) and the person alleged to have committed 
such violation of the results of the investigation conducted pursuant to this 
paragraph. Within 90 days of the receipt of such complaint the Secretary shall, 
unless the proceeding on the complaint is terminated by the Secretary on the 
basis of a settlement entered into by the Secretary and the person alleged to 
have committed such violation, issue an order either providing the relief pre- 
scribed by subparagraph (B) or denying the complaint. An order of the Secretary 
shall be made on the record after notice and opportunity for agency hearing. 
The Secretary may not enter into a settlement terminating a proceeding on a 
complaint without the participation and consent of the complaimint. 

(B) If in response to a complaint filed under paragraph (1) the Secretary 
determines that a violation of subsection (a) of this section has occurred, the 
Secretary shall order (i) the person who committed such violation to take 
affirmative action to abate the violation, (ii) such person to reinstate the com- 
plainant to the complainant's former position together with the comi)ensation 
(including back pay), terms, conditions, and privileges of the complainant's em- 
ployment, (iii) comi)ensatory damages, and (iv) where appropriate, exemplary 
damages. If such an order is issued, the Secretary, at the request of the com- 
plainant shall assess against the person against whom the order is issued a 
sum equal to the aggregate amount of all costs and expenses (including attorney's 
fees ) reasonably incurred, as determined by the Secretary, by the complainant 
for, or in connection with, the bringing of the complaint upon which the order 
was issued. 

(c) REv^EW. — (1) Any person adversely affected or aggrieved by an order 
issued under subsection (b) may obtain review of the order in the United States 
Court of Appeals for the circuit in which the violation, with respect to which 
the order was issued, allegedly occurred. The petition for review must be filed 
within 60 days from the issuance of the Secretary's order. Review shall conform 
to chapter 7 of title 5 of the United States Code. 

(2) An order of the Secretary, with resx)ect to which review could have been 
obtained under paragraph (1), shall not be subject to judicial review in any 
criminal or other civil proceeding. 

(d) Enforcement. — (1) Whenever a person has failed to comply with an 
order issued under subsection (b)(2), the Secretary shall file a civil action 
in the United States district court for the district in which the violation was 
found to occur to enforce such order. In actions brought under this subsection, 
the district courts shall have jurisdiction to grant all appropriate relief, includ- 
ing injunctive relief and compensatory and exemplary damages. Civil actions 
brought under this subsection shall be heard and decided expeditiously. 

(2) Any nondiscretionary duty imposed by this section is enforceable in a 
mandamus proceeding brought under section 1361 of title 28, United States 
Code. 



291 



(e) Exclusion. — Subsection (a) of this section shall not apply with respect 
to any employee who, acting without direction from the employee's employer 
(or any agent of the employer), deliberately causes a violation of any require- 
ment of this Act. 

(f) Employment Effects. — (1) The Administrator shall conduct continuing 
evaluations of the potential loss or shifts of employment which may result from 
the issuance of any rule or order under this Act, including, where appropriate, 
investigating threatened plant closures or reductions in employment allegedly 
resulting from such rule or order. 

(2) Any employee who is discharged or whose employment is otherwise 
interrupted, or is threatened with discharge or such interruption, or otherwise 
discriminated against by any person because of the results of any rule or order 
issued under this Act, or a representative of such employee, may request the 
Administrator to conduct a full investigation of the matter. The Administrator 
shall thereupon investigate tlie matter and. at the re(iuest of any interested party, 
shall hold a public hearing on not less than 5 days notice, and shall at such 
hearings require the parties, including the employer involved, to present infor- 
mation relating to the actual or potential effect of such rule or order on employ- 
ment and on any alleged discharge, interruption of employment, or other discrimi- 
nation and the detailed reasons or justification therefor. Any such hearing shall 
be of record and shall be conducted in accordance with section 554 of title 5, 
United States Code. 

(3) Upon receiving the report of any such investigation, the Administrator 
shall make findings of fact as to the effect of such rule or order on employment 
and the alleged discharge, interruption of employment, or discrimination and 
shall make such recommendations as he deems appropriate. Such report, find- 
ings, and recommendations shall be available to the public. 

(4) Notliing in this subsection shall be construed to require the Administrator 
to modify or withdraw any rule or order issued under this Act. 

STUDIES 

Sec. 24. (a) Indemnification. — The General Accounting OflSce shall conduct 
a study of all Federal laws administered by the Administrator for the purpose 
of determining whether and under what conditions, if any, indemnification 
should be accorded any person as a result of any action taken by the Adminis- 
trator under any such law. The study shall — 

(1) include an estimate of the probable cost of any indemnification 
programs which may be recommended ; 

(2) include an examination of all viable means of financing the cost 
of any recommended indemnification ; and 

(3) be completed and submitted to Congress not less than 2 years from 
the date of enactment of this Act. 

(b) Classification. Storage, and Retrieval. — The Council on Environmental 
Quality, in consultation with the Administrator, the Secretary of Health, Edu- 
cation, and Welfare, the Secretary of Commerce, and the heads of other appro- 
priate Federal departments or agencies, shall coordinate a study of the feasibil- 
ity of establishing (1) a standard classification system for chemical substances 
and related substances, and (2) a standard means for storing and for obtaining 
rapid access to information respecting such substances. A report on such study 
shall be completed and submitted to Congress not later than 18 months after 
the date of the enactment of this Act. 

state demonstration programs 

Sec. 25. (a) Establishment of Program. — The Administrator is authorized 
to assist no more than three states in establishing demonstration programs by 
such States to protect against unreasonable risks to health or the environment 
associated with chemical substances and mixtures. Such programs shall — 

(A) identify and inventory chemical substances and mixtures within such 
State, including their manufacture, processing, distribution, use, and 
disposal ; 

(B) monitor the extent to which such chemical substances or mixtures 
are present in the environment of such State and the human exposure to 
such substances or mixtures within such State; 

(C) establish a program to (i) prevent or eliminate unreasonable risks 

to health or the environment presented by chemical substances or mixtures, 
(ii) integrate the control of chemical substances and mixtures under this 



292 I 

section with other programs or environmental and public health protection 
within such State so as to appropriately minimize the overall pollution of 
the environment within such State; and (iii) identify the appropriate 
governmental institutions and processes necessary to implement a program 
for the prevention of unreasonable risks to health or the environment 
presented by chemical substances and mixtures : 

(D) analyze and evaluate the results of such programs through annual 
reports to the Administrator ; and 

(E) complement and in no way reduce Federal efforts under this Act 
in such State. 

{[)) Rkports. — The Administrator shall submit a report to the appropriate 
commitees of Congress not later tlian July 1 of each calendar year. Such report 
shall inchide (1) a description of progress with respect to programs as.'-isted 
under this section and any suggestions for improvement in such program, (2) 
recommendations as to the manner by which programs within the States for the 
pre^■ention of unreasonable risk to health jr the environment presented by 
chemical substances may feasibly be implemented, and (3) the extent to which 
the Administrator has disseminated information regarding programs authorized 
under this section to other interested States and other persons. 

(c) Authorization fob Appropriations. — For the purposes of providing 
assistance under this section, there are hereby authorized to be appropriated 
not to exr^eed $2,0(K),00() for the fiscal year ending September 30, 1977 : $2,(K)O.()00 
for the fiscal year ending September 30, 1978, and $2,000,000 for the fiscal year 
ending on September 30, 19 « 9. Any funds appropriated under the authority of 
this subsection shall remain available until exj^ended. Funds available under 
this section shall not be available for programs which would duplicate any 
authority or requirements of the Administrator under this Act, including sections 
4, 5, 6, and 9(c). Funds available under the authority of this section shall sup- 
port not more than 75 percent of the costs of any such program described under 
subsection (a) engaged in by the State. 

(d) Prioritees. — Assistance afforded under this section shall be available 
(subject to the requirements of subsection (a)) to those States which can 
establish a priority need for such assistance, as determined by ti)e rules of the 
Administrator. In establishing such rules, the Administrator shall consider the 
existence of serious health effects associated with chemical substances within 
such State including cancer, birth defects, and gene mutations; the extent to 
which chemical substances and mixtures are manufactured, processed, dis- 
tributed in commerce, used and disposed of within such State ; and the extent 
of exposure of human beings and the environment to chemical substances and 
mixtures within such State. The Administrator shall approve all such programs 
and estal)lish a mechanism for monitoring such programs. 

(e) Disci^\iMER. — Nothing contained in this section shall affect any provision 
of section 18 of this Act. 

administration of act 

Sec. 26. (a) Cooperation of Federal Agencies. — Upon request by the Admin- 
istrator, each Federal department and agency is authorized — 

(1) to make its services, personnel, and facilities available (with or with- 
out reimbursement) to the Administrator to assist the Administrator in the 
administration of this Act ; and 

(2) to furnish to the Administrator such information, data, estimates, and 
statistics, and to allow the Administrator access to all information in its 
possession as the Administrator may reasonably determine to be necessary 
for the administration of this Act. 

(b) Fees. — The Administrator may, by rule, require the payment of a reason- 
able fee from any person required to submit data under section 4 or 5 of this 
Act to defray the costs of administering this Act. Such rules shall not provide 
for any fee in excess of $2,500. In setting such a fee, the Administrator shall 
take into account the ability to pay of the person required to submit the data 
and the cost to the Administrator of reviewing such data. Such rules may pro- 
vide for sharing such a fee in any case in which the expenses of testing are 
shared under section 4 or 5 of this Act. 

(c) Action With Respect to Categories. — (1) Any action which may be 
taken by the Administrator under any i)rovision of this Act with respect to a 
chemical substance or mixture may be taken by the Administrator in accordance 
with that provision with respect to a category of chemical substances or mix- 
tures. Whenever the Administrator takes action under a provision of this Act 



293 



with respect to a category of chemical substances or mixtures, any reference in 
this Act to a chemical substance or mixture (insofar as it rr'lates to such action) 
shall be deemed to be a reference to all chemical substances or mixtures in such 
category. 

(2) For purposes of paragraph (1) : 

(A) The term "category of chemical substances" means a group of chem- 
ical substances the members of which are similar in molecular structure, 
in physical, chemical, or biological properties, in use, or in mode of entrance 
into the human body or into the environment, or the members of which are 
in some other way suitable for classification as such for purposes of this 
Act, except that such term does not mean a group of chemical substances 
which are grouped together solely on the basis of their being new chemical 
substances. 

(B) The term '"category of mixtures" means a group of mixtures the 
members of which are similar in molecular structure, in physical, chemical, 
or l)iological properties, in use, or in mode of entrance into the human 
body or into the environment, or the members of which are in some other 
way suitable for classification as such for purposes of this Act. 

(d) Statement of Purpose and Justification. — Any proposed or final rule 
or order issued under this Act shall be accompanied by a statement of purpose 
and justification. Such a statement shall be considered part of the "record of 
the proceedings" for purposes of judicial review under section 19(a). 

(e) Assistant Administrator. — The I'resident, by and with the advice and 
consent of the Senate, shall appoint an Assistant Administrator for Toxic 
Substances of the Environmental Protection Agency. Such Assistant Adminis- 
trator shall be a qualified individual who is, by reason of background and ex- 
perience, especially qualified to direct a program concerning the effects of 
chemicals on human health and the environment. Such As.sistant Administrator 
shall be responsible for the collection of data, the preparation of studies, and 
the making of recommendations to the Administrator for regulatory and other 
actions to carry out the purposes, and to facilitate the administration of this 
Act. 

authorization for appropriations 

Sec. 27. (a) In General. — There is authorized to be ap])ropriated to the Ad- 
ministrator, for purposes of carrying out this Act, $11.(K)(>,000 for the fiscal year 
ending June 30, 1976, $2.6(K).()()() for the period beginning July 1 1976 and ending 
September 30, 1976, and $10,100,000 for the fiscal year ending September 30. 
1977. No part of the funds so authorized to be appropriated shall be used to con- 
struct any research laboratories. 

(b) Budget Requests. — Whenever the Administrator directly or indirectly 
submits in connection with this Act, any budget requests, supplemental budget 
estimates, legislative recommendations, prepared testinnmy for congressional 
hearings, or comments on legislation to the Pre.sident or to tiie Office of Manage- 
ment and Budget, or persons acting on their behalf, the Administrator shall con- 
currently transmit a copy thereof to the Congress. No oflficer or agency of the 
United States shall have any authority to require the Administrator to submit 
budget requests or estimates, legislative recommendations;, prepared testimony 
for congressional hearings, or connnents on legislation relating to this Act to 
any officer or agency of the I'nitod States for approval, comments, or review, 
prior to the submis.sion of such requests, estimates, recommendations, testi- 
mony, or comments to the Congress. 

annual report 

Sec. 28. The Administrator shall prepare and submit to the President and 
the Congress on or before January 1 of each year a comprehensive report on 
the administration of this Act during the preceding fiscal year. Such report 
shall include — 

(1) a list of the testing required under section 4 during the year for 
which the report is made and an estimate of the costs Incurred during 
such year by the persons required to perform such tests : 

(2) the number of notices received during such year under section 5, the 
number of such notices received during such year under such section for 
chemical substances and mixtures subject to a section 4 rule, and a sum- 
mary of any action taken during such year under section 5(e) ; 



294 



(3) a list of rules issued during such year under section 6 ; 

(4) a list, with a brief statement of the issues, of completed or pending 
judicial or enforcement actions under this Act during such year ; 

(5) a summary of major problems encountered in the administration of 
this Act ; and 

(6) such recommendations for additional legislation as the Administrator 
deems necessary to carry out the purposes of this Act. 

Mr. Hartke subsequently said : Mr. President, in view of the large 
vote by which the toxic substances bill was passed, I would like to 
point out this matter has now been pending as a matter of request 
from the administration since February of 1970, and we have worked 
very closely with some ^lembers of the House of Representatives, and 
I would hope that the House would give urgent consideration to com- 
ing forward now with legislation which will not be stalemated as it 
has been in the past. 

There is not need for us to delay any longer the protection which 
could be afforded to millions of Americans simply by the utilization 
of the scientific method of telling the people what they need to know. 
I think it is high time that w^e eliminate the scare tactics which fre- 
quently are put forward about some item which may be dangerous to 
the health or environment and, at the same time, prove at a later date 
that it is not. 

On the other hand, there are thousands and thousands of items 
which, at this moment, still are going undetected and unknown by 
millions of Americans and it is high time we recognized that they are 
entitled not alone to the right to know but the right to have the 
Administrator of the Environmental Protection Agency to move 
effectively and immediately to do what he can to provide better health 
and a cleaner environment for Americans. 

Mr. Talmadge. Mr. President, if the distinguished Senator from 
California and the distinguished Senator from Kansas will give me 
their attention, there are two questions I desire to propound on this 
bill. 

I ask the distinguished floor manager of the bill : A^^lat effect would 
this legislation have upon the small bulk blend fertilizer operator 
who, in response to a farmer's request, changes the fertilizer mix ratio 
and perhaps add a pesticide? 

Mr. TuxxEY. It would have no effect if this mixture is« classified 
as a pesticide under the pesticide law. 

Mr. Talmadge. Does the Senator from Kansas share that view? 

^Ir. Pearson. I share that view. 

Mr. Talmadge. One further inquiry: \\Tiat sort of individual 
recordkeeping and notification requirements would be made of this 
small fertilizer operator? 

Mr. TuxxEY. Xone, if the mixture is classified as a pesticide under 
the i^esticide law. 

Mr. Pearsox. The answer is in the negative, no. 

Mr. Talmadge. Does the Senator from Kansas share that view? 

Mr. Pearson. Yes. 

Mr. Talmadge. I thank the Senators. 



CHAPTER III 



H.R. 14032 TOGETHER WITH EEPORT AND DEBATE 

Note. — H.R. 14032 was the last of several versions of the Toxic Substances 
Control Act introduced in the House ; early versions on which hearings were 
held included H.R. 7229, H.R. 7548, and H.R. 76G4. and a later version reported 
by the Subcommittee on Consumer Protection and Finance was H.R. 10318. 



297 



Union Calendar No. 694 

~ H. R. 14032 

[Report No. 94-1341] 



IN THE HOUSE OF REPRESENTATIVES 

IVIay 26, 1976 

Mr. EcKHARDT (for himself, Mr. Broyhill, Mr. Murphy of New York, Mr. 
Van Deerlin, Mr. Moss, Mr. Rooney, Mr. Scheuer, Mr. Carney, Mr. 
MoFFETT, Mr. RiNAUX), and Mr. Lent) introduced the following bill; 
which was referred to the Committee on Interstate and Foreign Commerce 

July 14,1976 

Reported with an amendment, committed to the Committee of the Whole House 
on the State of the Union, and ordered to be printed 

[Strike out all after the enacting clause and insert the part printed in italic] 



A BILL 

To regulate commerce and protect health and the environment 
by requiring testing and necessary restrictions on certain 
chemical substances and mixtures, and for other purposes. 

1 Be it enacted by the Senate and House of Representa- 

2 tives of the United States of America in Congress assembled. 



18 
19 



SHORT TITLE 

Section 1. This Act may he cited as the *'Toxk Sub- 
stances Control Acf\ 

TABLE OF CONTENTS 

Sec. 1. Short title. 

Sec. 2. Findings^ policy^ and intent. 

Sec. 3. Definitions. 

Sec. Jh Testing of chemical aiibstances and mimtures. 

Sec. 5. Manufacturing and processing notices. 

Sec. 6. Regulation of h/i^ardouschsmical substances arid miastures. 

Sec. 7. Imminent hazards. 

Sec. 8. Reporting and retention of information. 

Sec. 9. Relationship to other Federal laws. 

Sec. 10. Research, collection, dissemination, and utilization of data. 
Sec. 11. Inspections. 



• Line type deleted. 
79-313 O - 77 - 20 



298 



103 

TABLE OF CONTENTS— CoiitimieA 
Sec. 12. Exports. 

Sec. 13. Entry into customs territory of the United States. 
Sec. llh Disclosure of data. 
Sec. 15. Prohibited acts. 
Sec. 16. Penalties. 

Sec. 17. Specific enforcement and seizure. 

Sec. 18. Preemption. 

Sec. 19. Judicial review. 

Sec. 20. Citizens'' civil actions. 

Sec. 21. Citizens'' petitions. 

Sec. 22. National defense waiver. 

Sec. 23. Employee protection. 

Sec. 2J^. Employment effects. 

Sec. 26. Studies. 

Sec. 26. Administration of Act. 

Sec. 27. Development and evaluation of test methods. 

Sec. 28. Authorization for appropriatio7i». 

Sec. 29. AnnuM report. 

Sec. 30. Effective date. 

1 FINDINGS, POLICY, AND INTENT 

2 Sec. 2. (a) Findings.— The Congress finds that^ 

3 (1) humans and the environment are being exposed 

4 to a large number of chemical substances and mixtures 

5 each year; 

6 (2) among the many chemical substances and mix- 
tures constantly being developed and produced are some 

^ whose manufacture, processing, distribution in commerce, 
^ use, or disposal may cause or significantly contribute to 
1^ an unreasonable risk to health or the environment; and 
1^ (3) the effective regulation of interstate commerce 

in such chemical substances and mixtures also necessitates 
the regulation of intrastate commerce in such chemical 
substances and mixtures. 



299 
104 

1 (b) Policy. — It is the policy of the United States that— 

2 (1) hazardous and potentially hazardous chemical 

3 substances and mixtures should be adequately tested with 

4 respect to their effect on health and the environment and 

5 that such testing should be the responsibility of those 

6 who manufacture and those who process such chemical 

7 substances and mixtures; 

8 (2) adequate authority should exist to regulate 

9 chemical substances and mixtures which cause or signifi- 

10 cantly contribute to an unreasonable risk to health or the 

11 environment, and to take action with respect to chemical 

12 substances and mixtures which are imminent hazards; 
1^ and 

14 (3) authority over chemical substances and, mix- 

15 tures should be exercised in such a manner as not un- 
1^ duly to impede, or to create unnecessary economic bar- 
1'^ riers to, technological innovation while fulfilling the 
1® primary purpose of this Act to assure that such innova- 
1^ tion and commerce in such chemical susbtances and 

20 mixtures do not cause or significantly contribute to an 

21 unreasonable risk to health or the environment. 

22 (c) Intent of Congress. — It is the intent of Congress 
2^ that the Administrator shall carry out this Act in a reason- 
2^ able and prudent manner, and that the Administrator shall 



300 



105 

1 consider the environmental, economic, and social impact of 

2 any action the Administrator proposes to take under this Act. 

3 DEFINITIONS 

4 Sec. 3. As used in this Act: 

5 (1) The term ^^Administrator'' means the Administrator 

6 of the Environmental Protection Agency. 

7 (2) (A) Except as provided in subparagraph (B), the 

8 term "chemical substance'' means — 

9 (i) any organic or inorganic substance of a par- 

10 ticular molecular identity including a combination of 

11 such substances occurring (I) in whole or in part as a 

12 result of a chemical reaction, or (II) in nature, or 

13 (ii) any element or uncombined radical. 

14 (B) Such term does not include — 

15 (i) any mixture, 

16 (ii) any pesticide (as defined in the Federal In- 
secticide, Fungicide, and Rodenticide Act) when manu- 

1^ factured, processed, or distributed in commerce for use 

19 as a pesticide, 

20 (Hi) tobacco or any tobacco product, 

21 (iv) any source material, special nuclear material, 

22 or byproduct material ( as such terms are defined in the 

23 Atomic Energy Act of 1954 and regulations issued 

24 under such Act) , 



301 



106 

1 (v) any article the sale of which is subject to the 

2 ta<L imposed by section 4181 of the Internal Revenue 

3 Code of 1954 (determined without regard to any ex- 

4 emotions from such tax provided by section 4182 or 4221 

5 or any other provision of such Code) , and 

6 (vi) any food, food additive, drug, cosmetic, or 

7 device (as such term^ are defined in section 201 of the 

8 Federal Food, Drug, and Cosmetic Act) when manu- 

9 factured, processed, or distributed in commerce for use 

10 as a food, food additive, drug, cosmetic, or device. 

11 The term "food" as used in clause (vi) of this subparagraph 

12 includes poultry and poultry products ( as defined in sections 

13 4(e) and 4(f) of the Poultry Products Inspection Act), 

14 meat and m£at food products (as defined in section l(i) of 

15 the Federal Meat Inspection Act), and eggs and egg prod- 

16 ucts (as defined in section 4 of the Egg Products Inspection 
1'7 Act). 

18 (3J The term "commerce" means trade, traffic, or trans- 

19 portation (A) between a place in a State and any place out- 

20 side of such State, or (B) which affects trade, traffic, or 

21 transportation described in clause (A). 

22 (4) The term "distribute in commerce' or "distribu- 

23 tion in commerce'' when used to describe an action taken 

24 with respect to a chemical substance or mixture or article 

25 containing a substance or mixture means to sellf or the sale 



302 



107 

1 of, the substance, mixture, or article in commerce; to in- 

2 troduce or deliver for introduction into commerce, or the 

3 introducing or delivery for introduction into commerce of, 

4 the substance, mixture, or article; or to hold, or the holding 

5 of, the substance, mixture, or article after its introduction 

6 into commerce, 

7 (5) The term environment^^ includes water, air, and 

8 land and the interrelationship which exist among and be- 

9 tween water, air, and land and all living things. 

10 (6) The term ''health and safety study^' means any 

11 study of any effect of a chemical substance or mixture on 
' 2 health or the environment, including epidemiological studies, 
13 studies of occupational exposure to a chemical substance or 

mixture, toxicological, clinical, and ecological studies of a 
chemical substance or mixture, and any test performed pur- 
suant to this Act. 

(7) The term "manufacture'' means to import, produce, 

18 

or manufacture. 

(8) The term "mixture" means any combination of two 
or more chemical substances if the combination does not 
occur in nature and is not, in whole or in part, the result of 
a chemical reaction; except that such term does include a 
combination which occurs, in whole or in part, as a result of 

^ a chemical reaction if each of the chemical substances com- 



303 



108 



1 prising the combination is not a new chemical substance and 

2 if the combination could have been manufactured for commer- 

3 cial purposes without a chemical reaction at the time the 

4 chemical substances comprising the combination were com- 

5 bined. 

6 (9) The term ''new chemical substance^' means any 

7 chemical substance not included in the chemical substance 

8 list compiled and published under section 8(b). 

9 (10) The term "process'' means the preparation of a 

10 chemical substance or mixture for distribution in commerce — 

11 (A) in the same form or physical state, or in a 

12 different form or physical state from that, in which it 

13 was received by the person making such preparation, or 

14 (B) as part of an article containing the chemical 

15 substance or mixture, 

16 (11) The term "processor' means any person who 

17 processes a chemical substance or mixture. 

18 (12) The term "standards for the development of test 

19 data" means a prescription of — 



20 



(A) the— 



21 



23 



22 



(i) health and environmental effects, and 

(ii) information relating to toxicity, persistence, 
- and other characteristics which affect health and the 



24 



environment, 



25 



for which test data for a chemical substance or mixture 



304 



109 

1 are to he developed and any analysis that is to he per- 

2 formed on such data, and 

3 (B) to the extent necessary to assure that such data 

4 are reliable and adequate, the manner in which such 

5 data are to be developed, the specification of any test 

6 protocol or methodology to be employed in the develop- 

7 ment of such data, and such other requirements as are 

8 necessary to provide such assurance. 

9 (13) The term "State" means any of the several States, 

10 the District of Columbia, the Commonwealth of Puerto Bico, 

11 the Virgin Islands, Guam, the Canal Zone, American 

12 Samoa, or the Trust Territory of the Pacific Islands. 

13 (14) The term "United States'', when used in the 

14 geographic sense, means all the States. 

15 TESTING OF CHEMICAL SUBSTANCES AND MIXTURES 

1^ Sec. 4. (a) Testing Bequirements. — If the Ad- 

1'^ ministrator finds that — 

18 (l)(A)(i) the manufacture, distribution in com- 

19 merce, processing, use, or disposal of a chemical sub- 

20 stance or mixture or any combination of such actions 

21 may cause or significantly contribute to an unreasonable 

22 775^: to health or the environment, 

23 (ii) there are insufficient data and experience upon 

24 which the effects of such manufacture, distribution in 

25 commerce, processing, use, or disposal or combination of 



305 



110 

1 such actions on health or the environment can reason- 

2 a^ly be determined or predicted, and 

3 (Hi) testing of such substance or mixture with 

4 respect to such effects is necessary to develop such data; 

5 or 

6 (B)(i) a chemical substance or mixture is or will 

7 he produced in substantial quantities, and it enters or 

8 may reasonably be anticipated to enter the environment 

9 in substantial quantities or there is or may be signifi- 

10 cant or substantial human exposure to such substance or 

11 mixture, 

12 (ii) there are insufficient data and experience upon 

13 which the effects of the manufacture, distribution in 

14 commerce, processing, use, or disposal of such substance 
1^ or mixture or any combination of such actions on health 
16 or the environment can reasonably be determined or 
1'^ predicted, and 

18 (Hi) testing of such substance or mixture with re- 

19 spect to such effects is necessary to develop such data; 

20 and 

21 (2) in the case of a mixture, the effects which the 

22 mixture's manufacture, distribution in commerce, proc- 
2^ easing, use, or disposal or any combination of such ac- 
24 tions may have on health or the environment may not be 
2^ reasonably and more efficiently determined or predicted 



306 



111 

1 by testing the chemical substances which comprise the 

2 mixture; 

3 the Administrator shall by rule require that testing be con- 

4 ducted on such substance or mixture to develop data with 

5 respect to the health and environmental effects for which 

6 there is an insufficiency of daia and experience and which 

7 are relevant to a determination that the manufacture, distri- 

8 bution in commerce, processing, use, or disposal of such 

9 substance or mixture or any combination of such actions does 

10 or does not cause or significantly contribute to an unreason- 

11 able risk to health or the environment. 

12 (b)(1) Testing Requirement Rule.— A rule under 

13 subsection (a ) requiring the testing of a chemical substance or 

14 mixture shall include — 

15 (A) identification of the substance or mixture for 

16 which testing is required, 

17 (B) standards for the development of test data for 

18 such substance or mixture, and 

19 (C) a specification of the period ( which period may 

20 not be unreasonable) within which the persons required 

21 to conduct the testing shall submit to the Administrator 

22 data developed in accordance with the standards referred 

23 to in subparagraph (B). 

24 In determining the standards and period to be included, pur- 

25 suant to subparagraphs (B) and (C), in a rule under sub- 



307 
112 

1 section (a), the Administrator shall consider the relative 

2 costs of the various test protocols and methodologies which 

3 may he required under the rule and the reasonably foreseeable 

4 availability of facilities and personnel for performing testing 

5 under the rule. Such a rule may require the submission of 

6 preliminary data during the period prescribed under suh- 

7 paragraph (C) . 

8 (2) (A) The health and environmental effects for which 

9 standards for the development of test data may be pre- 

10 scribed include carcinogenesis, mutagenesis, terato genesis, 

11 behavioral disorders, cumulative or synergistic effects, and 

12 any other effect which may cause or significantly contribute 

13 to an unreasonable I'isk to health or the environment, and 

14 the characteristics of chemical substances and, mixtures for 
which such standards may be prescribed include persistence, 

1^ acute toxicity, subacute toxicity, chronic toxicity, and any 
other characteristic which may cause or significantly con- 

18 tribute to such a risk. The methodologies that may be pre- 

19 scribed in such standards include epidemiology, serial, or 

20 hierarchical tests; in vitro tests; and. whole animal tests. 

21 Before prescribing epidemiology tests in such standards, the 

22 Administrator shall consult with the Director of the National 
2*^ Institute for Occupational Safety and Health. 

24 (B) From time to time, but not less than once each 

25 twelve months, the Administrator shall review the adequacy 



308 



113 

1 of the standards for development of data prescribed in rules 

2 under subsection (a) and shall, if necessary, institute pro- 

3 ceedings to make appropriate revisions of such standards. 

4 (3) (A) A rule under subsection (a) respecting a chem- 

5 ical substance or mixture shall require the persons described 

6 in subparagraph (B) to conduct tests and submit data on 

7 such substance or mixture, except that the Administrator may 

8 permit two or more of such persons to designate one such 

9 person or a qualified third party to conduct such tests and 
10 submit such data on behalf of the persons making the 
H designation. 

12 (B) The following persons shall be required to conduct 
tests and submit data on a chemical substance or mixture suh- 

14 ject to a rule under subsection (a) : 

15 (i) Each person who manufactures or intends to 

16 manufacture such substance or mixture if the Adminis- 
1^7 trafor makes a finding described in subsection (a)(1) 

18 (A)(ii) or (a) (1) (B) (ii) with respect to the manu- 

19 facture of such substance or mixture. 

20 (ii) Each person who processes or intends to process 

21 such substance or mixture if the Administrator makes a 

22 finding described in subsection (a) (1) (A) (ii) or (a) 

23 (l)(B)(ii) with respect to the processing of such 
2^ substance or mixture. 



309 



114 

1 ( Hi) Each person who manufactures or processes or 

2 intends to manufacture or process such substance or mix- 

3 ture for diMrihution in commerce if with respect to the 

4 distribution in commerce of such substance or mixture 

5 the Administrator makes a finding described in siibsec- 

6 tion (a)(l)(A)(ii) or ( a) (1) (B ) (ii) . 

7 (iv) Each person who manufactures or processes oi' 

8 intends to manufacture or process such substance or mix- 

9 ture if with respect to the disposal of such substance or 

10 mixture the Administrator makes a finding described 

11 in subsection ( a) (1) ( A) (ii) or ( a) (1) (B ) (ii) . 

12 (v) Each person who manufactures or processes or 

13 intends to manufacture or process such chemical sub- 

14 stance or mixture for a use with respect to which the 

15 Administrator makes a finding described in subsection 

16 (a) (1) (A) (ii) or (a) (1)(B) (ii). 

17 ('^) A rule under subsection (a) requiring the testing of 



18 a chemical substance or mixture shall expire at the end of the 

19 reimbursement period (as defined in subsection (c) (3) (B) ) 

20 applicable to test data for such substance or mixture, unless 

21 the Administrator repeals the rule before such date. 

22 (5) Rules issued under subsection (a) (and any amend- 

23 ment thereto or repeal thereof) shall be promulgated pur- 

24 suant to section 553 of title 5, United States Code, except 



310 
115 

J that in promulgating, amending, or repealing any such rule 

2 (A) the Administrator shall give interested persons an op- 

3 portunity for the oral presentation of data, views, or argu- 

4 ments, in addition to an opportunity to make written suh- 

5 missions; and (B) a transcript shall he made of any oral 
g presentation. The Administrator may not promulgate a rule 
rj under subsection ( a) respecting a substance or mixture unless 
g the Administrator makes and publishes with the rule the find- 
9 ings described in paragraph (1) (A) or (1) (B) of such 

10 subsection and, in the case of a rule respecting a mixture, 

\1 the finding described in paragraph (2) of such subsection. 

12 (c) Exemption— (1) Any person required by a rule 

13 under subsection (a) to conduct tests and submit datd on a 

14 chemical substance or mixture may apply to the Adminis- 

15 trator ( in such form and manner as the Administrator shall 

16 prescribe) for an exemption from such requirement. 

17 (2) If, upon receipt of an application under paragraph 

18 (1), the Administrator determines that — 

19 (A) the chemical substance or mixture (including 

20 any contaminant present in such substance or mixture) 

21 with respect to which such application was submitted 

22 is equivalent to a chemical substance or mixture for 

23 which data has been submitted to the Administrator in 

24 accordance with a rule under subsection (a) or for 



311 



116 

1 which data is being developed pursuant to such a rule, 

2 and 

3 (B) submission of data by the applicant on such 

4 substance or mixture would be duplicative of data which 

5 has been submitted to the Administrator in accordance 

6 with such rule or which is being developed pursuant to 

7 such rule, 

8 the Administrator shall exempt, in accordance with para- 

9 graph (3) or (4), the applicant from conducting tests and 

10 submitting data on such substance or mixture. 

11 (3) (A) If the exemption of any person from the re- 

12 quirement to conduct tests and submit test data on a chemical 

13 substance or mixture is granted on the basis of the existence 

14 of previously submitted test data and if such exemption is 

15 granted during the reimbursement period for such test data 

16 (as prescribed by subparagraph (B)), then (unless such 
1*7 person and the persons referred to in rlauses (i) and (ii) 

18 agree on the amount and method of reimbursement) the Ad- 

19 ministrator shall order the person granted the exemption to 

20 provide fair and equitable reimbursement (in an amount 

21 determined under rules of the Administrator) — 

22 (i) to the person who previously submitted such test 

23 data, for a portion of the costs incurred by such person 
in complying with the requirement to submit such data, 

^ and 



312 



117 

1 (ii) to any other person who has been required 

2 under this subparagraph to contribute with respect to 

3 such costs, for a portion of the amount such person was 

4 required to contribute. 



5 In promulgating rules for the determination of fair and 

6 equitable reimbursement to the persons described in clauses 

7 (i) and (ii) for costs incurred with respect to a chemical 

8 substance or mixture, the Administrator shall consider all 

9 relevant factors, including the effect on the competitive 

10 position of the person required to provide reimbursement in 

11 relation to the persons to be reimbursed and the share of the 

12 market for such substance or mixture of the person re- 

13 quired to provide reimbursement in relation to the share of 

14 such market of the persons to be reimbursed. An order under 

15 this subparagraph shall, for purposes of judicial review, be 

16 considered final agency action . 



17 (B) For purposes of subparagraph (A), the reimburse- 

18 ment period for any test data for a chemical substance or 

19 mixture is a period — 

20 (i) beginning on the date such data was submitted 

21 in accordance with a rule promulgated under subsection 

22 (a), and 

23 (ii) ending — 

24 (I) five years after the date referred to in 

25 clause (i), or 



313 



118 

1 (II) at the expiration of a period which begins 

2 on the date referred to in clause (i) and is equal to 

3 the period which the Administrator determines was 

4 necessary to develop such data, 

5 whichever is later. 

6 (4) (A) If the exemption of any person from the require- 

7 ment to conduct tests and submit test data on a chemical 

8 substance or mixture is granted on the basis of the fact that 

9 test data is being developed by one or more persons pursuant 

10 to a rule promulgated under subsection (a), then ( unless such 

11 person and the persons referred to in clauses (i) and (ii) 

12 agree on the amount and method of reimbursement) the Ad- 

13 ministrator shall order the person granted the exemption to 
provide fair and equitable reimbursement (in an amount 
determined under rules by the Administrator) — 

(i) to each such person who is developing such test 

17 

data, for a portion of the costs incurred by each stick 

18 

person in complying with such rule, and 

(a) to any other person who has been required 

OA 

under this subparagraph to contribute with respect to 

21 

the costs of complying with such rule, for a portion of 

22 

the amount such person was required to contribute. 

23 

In promulgating rules for the determination of fair and 

24 

equitable reimbursement to the persons described in clauses 



79-313 O - 77 - 21 



314 



119 

1 (i) and (ii) for costs incurred with respect to a chemical 

2 substance or mixture, the Administrator shall consider the 

3 factors described in the second sentence of paragraph (3) 

4 (A). An order under this subparagraph shall, for purposes 

5 of judicial review, be considered final agency action. 

6 (B) If an exemption is granted on the basis of the fact 

7 that one or more persons are developing test data pursuant to 

8 a rule promulgated under subsection (a) and if after such 

9 exemption is granted the Administrator determines that no 

10 such person has complied with such rule, the Administrator 

11 shall (i) after providing written notice to the person who 

12 holds such exemption and an opportunity for a hearing, by 

13 order terminate such exemption, and (ii) notify in writing 
such person of the requirements of the rule with respect to 
which such exemption was granted. 

(d) Notice. — Upon the receipt of any test data pur- 
suant to a rule under subsection (a), the Administrator shall, 
subject to section 14, promptly publish a notice of the re- 
ceipt of such data in the Federal Register. Each such notice 
shall (1) identify the chemical substance or mixture for 
which data have been received; (2) list the uses or intended 
uses of such substance or mixture and the information re- 
quired by the applicable standards for the development of 
test data; and (3) describe the nature of the test data de- 



315 



120 

1 veloped. Except as otherwise provided in section 14, such 

2 data shall he made available by the Administrator for ex- 

3 amination by any person. 

4 (e) Priority List.— (1) (A) There is established a 

5 committee to make recommendations to the Administrator 

6 respecting the chemical substances and mixtures to which the 

7 Administrator should give priority consideration for the 

8 promulgation of a rule under subsection (a). In making such 

9 a recommendation with respect to any chemical substance or 

10 mixture, the committee shall consider all relevant factors, 

11 including — 



12 (i) the quantities in which the substance or mix- 

13 ture is or will be manufactured, 

14 (ii) the quantities in which the substance or mixture 

15 enters the environment, 

16 (Hi) the number of persons who will be exposed to 
1'7 the substance or mixture in their places of employment 

18 and the duration of such exposure, 

19 (iv) the extent of human exposure to the substance 

20 or mixture, 

21 (v) the extent to which the substance or mixture is 

22 closely related to a chemical substance or mixture which 

23 is known to cause or significantly contribute to an un- 

24 reasonable risk to health or ihe environment. 



316 



121 

1 (vi) the existence of data concerning the effects of 

2 the substance or mixture on health or the environment, 

3 (vii) the extent to which testing of the substance 

4 or mixture may result in the development of data upon 

5 which the effects of the substance or mixture on health 

6 or the environment can reasonably be determined or 

7 predicted, and 

8 ( viii) the reasonably foreseeable availability of facil- 

9 ities and personnel for performing testing on the sub- 

10 stance or mixture. 

11 The recommendations of the committee shall be in the form 

12 of a list of chemical substances and mixtures which shall 

13 be listed, either by individual substance or mixture or by 
groups of substances or mixtures, in the order in which 
the committee determines the Administrator should take 
action under subsection (a) with respect to the substances 
and mixtures. 

(B) Not later than twelve months after the effective 
1^ date of this Act, the committee shall transmit to the 
Administrator the list required by subparagraph (A) to- 
'^^ gether with the reasons for the committee's inclusion of each 
chemical substance or mixture on the lists. At least every six 
months after the transmission to the Administrator of the 
list pursuant to the preceding sentence, the committee shall 



317 



122 

make such revisions in the list as it determines to he neces- 

2 sary and shall transmit them to the Administrator together 

3 with the committee's reasons for th- ^'evisions. The Adminis- 

4 trator shall make available to the public the list transmitted 

5 by the committee, any revision by the committee in such list 

6 (including the date on which such revision was transmitted 

7 to the Administrator), and the reasons of the committee for 
g inclusion of a chemical substance or mixture on the list and 
9 for any revision in the list. The Administrator shall provide 

10 reasonable opportunity to any interested person to file with 

11 the Administrator written comments on the committee's list 

12 or any revision of the committee of such list and shall make 

13 such comments available to the public. 

14 (C) The Administrator may promulgate a rule under 

15 subsection (a) with respect to a chemical substance or mix- 

16 ture which is not contained on a list published under this 

17 subsection. 

18 (2) (A) The committee established by paragraph (1) 

19 (A) shall consist of eight members as follows: 

20 (i) One member (or designee of the member) ap- 

21 pointed from the Environmental Protection Agency by 

22 the Administrator. 

23 (ii) One member (or designee of the member) 

24 appointed by the Secretary of Labor from officers of 

25 the Department of Labor engaged in the Secretary's 



318 



123 

1 activities under the Occupational Safety and Health 

2 Act of 1970. 

3 (Hi) One member (or designee of the member) 

4 appointed from the Council on Environmental Quality 

5 by the Chairman of the Council. 

6 (iv) One member (or designee of the member) 

7 appointed from, the National Institute for Occupational 

8 Safety and Health by the Director of the Institute. 

9 (v) One member (or the designee of the member) 

10 appointed from the National Institute of Environmental 

11 Health Sciences by the Director of the Institute. 

12 (vi) One member (or designee of the member) 
appointed from the National Cancer Institute by the 
Director of the Institute. 

(vii) One member (or designee of the member) 
appointed from the National Science Foundation by 
the Director of the Foundation. 

(viii) One member (or designee of the member) 
appointed from the Department of Commerce by the 
Secretary of Commerce. 

A member may designate an individual to serve on the 
member's behalf only with the approval of the applicable 
appointing authority and only if the individual is from the 
entity from which the member was appointed. A vacancy in 



14 
15 
16 
17 
18 
19 
20 
21 
22 
23 
24 



319 



124 

1 the committee shall be filled in the same manner in which 

2 the original appointment was made. 

3 (B)(i) The term of office of a member of the committee 

4 is four years, except that of the members first appointed, 

5 four members shall have initial terms of two years. Any 
Q member appointed to fill a vacancy occurring prior to the 

7 expiration of the term for which the members predecessor 

8 was appointed shall be appointed only for the remainder of 

9 such term. If any member of the committee leaves the office 

10 or entity from which the member was appointed, such mem- 

11 ber may not continue as a member of the committee, and, for 

12 purposes of the preceding sentence, the member s position 

13 shall be considered as being vacant. A member may serve 

14 after the expiration of the member's term of office until a 

15 successor has taken office. 

16 (a) Initial appointments to the committee shall be made 

17 not later than the sixtieth day after the effective date of this 

18 Act. Not later than the ninetieth day after such date the 

19 members of the committee shall hold a meeting for the selec- 

20 lion of a chairman from among their number and to deter- 

21 mine, by lot, the four members ivho shall have initial terms 

22 of two years. 

23 (C) The Administrator shall provide the committee 

24 such administrative support services as may be necessary for 

25 the committee to carry out its function under this subsection. 



320 



125 

1 MANUFACTURING AND PROCESSING NOTICES 

2 Sec, 5. (a) Notification for Manufacture of 

3 New Chemical Substances —On and after the date on 

4 which the Administrator first publishes under section 8(h) 

5 a list of chemical substances manufactured or processed in 

6 the United States, no person may manufacture a new 

7 chemical substance unless (except as provided in subsection 

8 (i) (relating to exemptions) ) such person — 

9 (1) has, at least ninety days before such manu- 

10 facture, submitted to the Administrator, in accordance 

11 with subsection (f) (relating to notice content), a notice 

12 of such person's intention to manufacture such sub- 

13 stance, and 

(2) has complied with any applicable requirement 

1^ of subsection (d) (relating to submission of test data). 

1^ (b) Notification for the Manufacture or Proc- 

^'^ ESSiNG OF a Chemical Substance for a Significant 

1^ New Use. — (1) No person may manufacture or process a 

1^ chemical substance for a use which the Administrator has 

20 determined, in accordance with paragraph (2), is a signifi- 

21 cant new use of such substance unless (except as provided 

22 in subsection (i) ) such person — 

23 (A) has, at least ninety days before such manu- 
2^ facture or processing, submitted to the Administrator, in 
25 accordance with subsection (f), a notice of such person's 



321 



126 

1 intention to manufacture or process such substance for 

2 such use, and 

3 (B) has complied with any applicable requirement 

4 of subsection (d). 

5 (2) A determination by the Administrator that a new 

6 use of a chemical substance is a significant new use with 

7 respect to which notification is required under paragraph 

8 (1) or subsection (c)(1)(B) shall be made by a rule 

9 promulgated after a consideration of all relevant factors, 

10 including — 

11 (A) the projected volume of manufacturing and 

12 processing of such substance for such use, 

13 (B) the extent to which such use changes the type 

14 or form of exposure of humans or the environment to 
1^ such substance, and 

1^ (C) the extent to which such use increases the mag- 

nitude and duration of exposure of humans or the en- 
1^ vironment to such substance. 

1^ The last sentence of section 19(c)(1) shall not apply to 

20 judicial review of any rule promulgated under this para- 
graph. 

22 (c) Notification for the Manufacture or Proc- 

23 EssiNG OF Listed Chemical Substances.— (1) (A) 

24 No person may manufacture a chemical substance — 

25 (i) which is listed under paragraph (2), and 



322 



127 

1 (ii) which was a new chemical substance at the 

2 time of publication of the earliest proposed rule under 

3 paragraph (2) listing such substance, 

4 unless ( except as provided in subsection (i) ) such person 

5 ha^, at least ninety days before such manufacture, submitted 

6 to the Administrator, in accordance with subsection (f), a 

7 notice of such persons intention to manufacture such sub- 

8 stance and has complied with the requirement of subsection 

9 (d). 

10 (B) No person may manufacture or process a chemical 

11 substance, listed under paragraph (2), for a use which the 

12 Administrator has determined, in accordance with subsection 

13 (b)(2), is a significant new use of such substancp unless 

14 (except as provided in subsection (i)) such person — 

1^ (i) has, at least ninety days before such manufac- 

1^ ture or processing, submitted to the Administrator, in 
a^cordarice with subsection (f), a notice of such per- 
1^ son^s intention to manufacture or process such substance 

19 for such use, and 

20 (a) has complied with the requirement of subsection 

21 (d). 

22 (2)(A)(i) Within twelve months after the effective date 

23 of this Act, the Administrator shall, by rule, compile, and 

24 from time to time thereafter revise, a Ivit of chemical sub- 
2^ stances the manufacture, processing, distribution in com- 



323 



128 

1 merce, use, or disposal of which, or any combination of such 

2 actions respecting which, the Administrator finds causes or 

3 significantly contributes to or may cause or significantly con- 

4 tribute to an unreasonable risk to health or the environment. 

5 (ii) In making a finding under clause (i) that the 

6 manufacture, processing, distribution in commerce, use, or 

7 disposal of a chemical substance or any combination of such 

8 actions causes or significantly contributes to or may cause or 

9 significantly contribute to an unreasonable risk to health or 

10 the environment, the Administrator shall consider all rele- 

11 vant factors, including — 

12 (I) the effects of the chemical substance on health 

13 amd the magnitude of human exposure to it; and 

14 (II) the effects of the chemical substance on the 

15 environment and the magnitude of environmental ex- 

16 posure to it. 

17 (B) The Administrator shall, in prescribing a rule under 

18 subparagraph (A) which lists any chemical substance, 

19 identify those uses, if any, which the Administrator deter- 

20 mines, in accordance with subsection (b)(2), would consti- 

21 tute a significant new use of such substance. The last sen- 

22 tence of section 19(c)(1) shall not apply to judicial revieiv 

23 of any provision of a rule under subparagraph (A) which 

24 provision is prescribed pursuant to this subparagraph. 

25 (C) Any rule under subparagraph (A), and any 



324 



129 

1 amendment or repeal of such a rule, shall be promulgated 

2 pursuant to the procedures specified in section 558 of title 5, 

3 United States Code, except that (i) the Administrator shall 

4 give interested persons an opportunity for the oral presenta- 

5 tion of data, views, or arguments, in addition to an oppor- 

6 tunity to make written submissions, and (ii) a transcript 

7 shall he kept of any oral presentation. The Administrator 

8 m,ay not promulgate under subparagraph (A) a rule listing 

9 a chemical substance unless the Administrator makes and 

10 publishes with the rule the finding described in such sub- 

11 paragraph. 

12 ( d) Requirement Respecting Submission of Test 

13 Data.—(1)(A) If— 

14 (i) a person is required by subsection (a), (b), or 

15 (c) to submit a notice to the Administrator before be- 
1^ ginning the manufacture or processing of a chemical 

substance, and 

1^ (ii) such person is required to submit test data for 

19 such substance pursuant to a rule promulgated under 

20 section 4 before the submission of such notice or such 

21 person has been granted an exemption under section 4 

22 (c) from the requirement of such rule, 

2^ such person may not, before the expiration of the period pre- 

2^ scribed by subparagraph (B), manufacture such substance 
if the person is subject to subsection (a) or (c)(1)(A) or 



325 



130 

1 manufacture of process such substance for a significant new 

2 use if the person is subject to subsection (b) or (c) (1) (B) . 



3 (B) The period referred to in subparagraph (A) is — 

4 (i) in the case of a person required to submit test 

5 data pursuant to a rule promulgated under section 4 ( a) 

6 a period of ninety days which begins on the date on 

7 which such person submits to the Administrator such 

8 data in accordance with such rule, and 

9 (a) in the case of a person who under section 4(c) 
10 is exempt from a requirement to submit test data pursu- 
1.1 ant to a rule promulgated under section 4(a), a period of 

2 ninety days which begins on the date of the submission in 

13 accordance with such rule of the test data the submission 

14 or the development of which was the basis for the 

15 exemption. 

16 (2) (A) If- 

17 (i) a person is required by subsection (c) to sub- 

18 mit a notice to the Administrator before beginning the 

19 manufacture or processing of a chemical substance, and 

20 (a) (I) a rule promulgated under section 4 before 

21 the submission of such notice requiring the submission of 

22 test data for such substance does not require such person 

23 to submit such data, or 

24 (II) the Administrator has not promulgated such a 



326 



131 

1 rule for such substance before the submission of such 

2 notice, 

3 such person may not, before the expiration of the ninety-day 

4 period which begins on the date such person submits to the 

5 Administrator data prescribed by subparagraph (B), manu- 

6 facture such substance if such person is subject to subsection 

7 (c)(1)(A) or manufacture or process such substance for a 

8 significant new use if such person is subject to subsection 

9 (c)(1)(B). 

10 (B) Data submitted pursuant to subparagraph (A) 

11 shall be data which the person submitting the data believes 

12 show that — 

13 (i) in the case of a substance for which notice is 

14 required under subsection (c) (1) (A), the manufacture, 

15 processing, distribution in commerce, use, and disposal 

16 of the chemical substance or any combination of such 

17 actions would not cause or significantly contribute to an 

18 unreasonable risk to health or the environment, or 

19 (ii) in the case of a chemical substance for which 

20 notice is required under subsection (c) (1) (B) , the in- 

21 tended significant new use of the chemical substance 

22 would not cause or significantly contribute to an unrea- 

23 sonable risk to health or the environment. 

24 (3) Data submitted under paragraph (1) or (2) shall 



327 



132 

1 be made available, subject to section 14, for examination 

2 by interested persons. 

3 (e) Extension of Notice Period.— The Administrator 

4 may for good cause extend for one additional period of 

5 not to exceed ninety days the period, prescribed by subsec- 

6 tion (a), (b), (c), or (d), before ivhich the manufacturing or 

7 processing of a chemical substance subject to such subsection 

8 may begin. Subject to section 14, such an extension and the 

9 reasons therefor shall be published in the Federal Register 

10 and shall constitute a final agency action subject to judicial 

11 review. 

12 (f) Content of Notice; Publication in the 

13 Federal Register. — (1) The notice required by sub- 

14 sections (a), (b), and (c) respecting a chemical substance 

15 shall include — 

16 (A) the name of the chemical substance; 

1*7 (B) the chemical identity and molecular structure 

18 of the substance, insofar as such are reasonably ascer- 

19 tainable; 

20 (C) the proposed categories of use of such sub- 

21 stance, insofar as such are reasonably ascertainable; 

22 (D) a reasonable estimate of the amount of the sub- 

23 stance to be manufactured or processed and, insofar as 

24 reasonably ascertainable, a reasonable estimate of the 



328 



133 

1 amount of the substance to be manufactured or proc- 

2 essed for each proposed category of use of the substance; 

3 (E) a description of the byproducts, if any, result- 

4 ing from the manufacture, processing, use, or disposal of 

5 the substance, insofar as such are reasonably ascertain- 

6 able; and 

7 (F) any test data in the possession or control of 

8 the person giving such notice which are related to the 

9 effect on health or the environment of any manufac- 

10 ture, processing, distribution in commerce, use, or dis- 

11 posal of the substance or any article containing such 

12 substance, 

13 Such a notice shall be made available, subject to section 14, 
for examination by interested persons. 

(2) Subject to section 14, not later than five days (ex- 
eluding Saturdays, Sundays and legal holidays) after the 
date of the receipt of a notice under subsection (a), (b), or 
(c) or data under subsection (d) the Administrator shall 
1^ publish in the Federal Register a notice which — 

20 (A) identifies the chemical substance for which 

21 notice or data has been received; 

22 (B) lists the uses or intended uses of such sub- 

23 stance; and 

(C) in the case of the receipt of data under sub- 



329 



134 

1 section (d), describes the nature of the tests performed 

2 on such substance and any data which was developed 

3 pursuant to subsection (d) or a rule under section 4. 

4 Notice under this paragraph respecting a chemical substance 

5 shall identify the chemical substance by generic class unless 
5 the Administrator determines that more specific identification 

7 is required in the public interest. 

8 (g) Regulation Pending Development of In- 

9 formation .—(1) (A) The district courts of the United 

10 States shall, upon application of the Administrator made 

11 through attorneys of the Environmental Protection Agency, 

12 have jurisdiction to enjoin in accordance tuith subparagraph 

13 (B), the manufacture, processing, or distribution in coni- 
1^ merce of a chemical substance subject to a notification require- 
1^ ment of subsection (a), (b), or (c) if the court find.^ that — 

(i) information available to the Administrator is 
insufficient to permit a reasoned evaluation of the effects 
on health or the environment of the manufacture, process- 
1^ ing, distribution in commerce, use, or disposal of such 

20 chemical substance or any combination of such actions, 

21 and 

22 (a) in the absence of such information, the manu- 
2^ facture, processing, distribution in commerce, use, or dis- 
2^ ■ posal of such substance or any combination of such actions 



79-313 - 77 - 22 



330 



135 

1 may cause or significantly contribute to an unreasonable 

2 risk to health or the environment. 

3 (B) An injunction issued under subparagraph (A) 

4 with respect to a chemical substance subject to a notification 

5 requirement under subsection (b) or (c)(1)(B) respecting 

6 a significant new use of such substance shall apply only to 

7 the manufacture, processing, or distribution in commerce, 

8 as the case may be, of the substance for such use. 

9 (C) An injunction issued under subparagraph (A) 

10 with respect to a chemical substance shall expire — 

11 (i) upon the expiration of the five-day period be- 

12 ginning on the day after the issuance of the injunction, 
^'^ if the Administrator does not within such period publish 

the notice required by paragraph (2), or 

(ii) if the Administrator publishes such notice with- 

in such period, upon the completion or termination of 

the proceeding begun by publication of such notice. 

(2) (A) Within five days after the issuance of an in- 
junction under paragraph (1) ivith respect to a chemical 
substance, the Administrator shall publish, in accordance 
with section 553(b) of title 5, United States Code, a general 
notice of proposed rulemaking to begin proceedings for the 
promulgation of a rule to apply to such substance one or 
^ more of the requirements described in section 6 ( a) as is 



331 



136 

1 necessary to adequately protect against the risk to health or 

2 the environment found by the court under paragraph (1) 

3 (A)(U). 

4 (B) Upon publication of such a notice the Administrator 

5 shall, as expeditiously as possible, provide reasonable oppor- 

6 tunity for a hearing (in accordance with paragraphs (2) 

7 and (3) of section 6(c)) on such proposed rule, and either 

8 adopt such rule (as proposed or with modifications) or by 

9 notice published in the Federal Register terminate the pro- 

10 ceeding for the promulgation of the rule. If such a hearing 

11 is requested, the Administrator shall commence the hearing 

12 within fifteen days from the date such request is made unless 

13 the Administrator and each person making the request agree 
1^ upon a later date for the hearing to begin, and after the 
1^ hearing is concluded the Administrator shall, within thirty 

days of the conclusion of the hearing, either adopt such rule 
■^'^ (as proposed or with modifications) or terminate the proceed- 

ing (as prescribed in the preceding sentence). 

(3) After a rule promulgated under paragraph (2) has 

taken effect any person may petition the Administrator to 
^■^ initiate a proceeding to amend or repeal such rule. Within 

thirty days of the receipt of such a petition, the Adminis- 

trator shall by order either grant or deny the petition. If the 
^ Administrator grants such petition, the Administrator shall 

promptly initiate a proceeding for the amendment or repeal, 



332 



137 

1 as the case may 6e, of such rule. Such a proceeding shall be 

2 conducted in accordance with paragraphs (2) and (3) of 

3 section 6(c). 

4 (h) Petition for Standards for the Develop- 

5 MENT of Test Data. — A person intending to manufacture 

6 or process a chemical substance for which notice is required 

7 under subsection (a), (b), or (c) and who is not required 

8 under a rule under section 4 to conduct tests and submit data 

9 on such substance may petition the Administrator to pre- 

10 scribe standards for the development of test data for such 

11 substance. The Administrator shall either grant or deny 

12 any such petition within sixty days of its receipt. If the 

13 petition is granted ^ the Administrator shall prescribe such 
standards for such substance within seventy-five days of the 

1^ date the petition is granted. If the petition is denied, the 

1^ Administrator shall publish in the Federal Register the 

reasons for such denial. 
1^ (i) Exemption. — (1) The Administrator may, upon 

1^ application (made in such form and manner as the Ad- 

20 ministrator may prescribe) exempt any person from the re- 

21 quirement of subsection (a), (b), (c), or (d) or of any 

22 combination of such subsections to enable such person to 
2^ manufacture or process a chemical substance for test market- 

ing purposes — 

25 (A) upon a showing by such person satisfactory 



333 



138 

"1^ to the Administrator that the manufacture, processing, 

2 distribution in commerce, use, and disposal of such suh- 

3 stance for such purposes would not cause or significantly 

4 contribute to any unreasonable risk to health or the envi- 

5 ronment, and 

6 (B) under such restrictions as the Administrator 

7 considers appropriate. 

8 Within forty-five days of the receipt of an application under 

9 this paragraph the Administrator shall either approve 

10 deny such application. 

11 (2) (A) The Administrator may upon application 

12 (made in such form and manner as the Administrator may 

13 prescribe) exempt any person from the requirement of sub- 

14 section (d)(2) to submit data for a chemical substance. 
1'^ //, upon receipt of an application under the preceding sen- 
1^ tencey the Administrator determines that — 

( i) the chemical substance ( including any contami- 
nant present in such substance) with respect to which 

19 such application was submitted is equivalent to a chemi- 

20 cal substance for which data has been submitted to the 

21 Administrator in accordance with subsection (d)(2), 

22 and 

2^ (a) submission of data by the applicant on such 

24 substance would be duplicative of data which has been 



334 



139 

1 submitted to the Administrator in accordance with such 

2 subsection, 

3 the Administrator shall exempt the applicant from submit- 

4 ting such data on such substance. No exemption granted 

5 under this subparagraph with respect to the submission of 

6 data for a chemical substance may take effect before the 

7 beginning of the reimbursement period applicable to such 

8 data. 

9 (B) If the Administrator, under subparagraph (A), 

10 exempts any person from submitting under subsection (d) 

11 (2) data for a chemical substance because of the existence of 

12 previously submitted data and if such exemption is granted 

13 during the reimbursement period for such data, then ( unless 
such person and the persons referred to in clauses (i) and 
(ii) agree on the amount and method of reimbursement) 
the Administrator shall order the person granted the exemp- 
tion to provide fair and equitable reimbursement (in on 
amount determined under rides of the Administrator) — 

(i) to the person who previously submitted the 
29 data on which the exemption icas based, for a portion of 
2-^ the costs incurred by such person in complying with the 
22 requirement under subsection (d)(2) to submit such 
2^ data, and 

2^ ( ii) to any other person who has been required 



335 



140 

1 under this subparagraph to contribute with respect to 

2 such costs, for a portion of the amount such person was 

3 required to contribute. 



4 In promulgating rules for the determination of fair and 

5 equitable reimbursement to the persons described in clauses 
Q (i) and (ii) for costs incurred with respect to a chemical 

7 substance, the Administrator shall consider all relevant fac- 

8 tors, including the effect on the competitive position of the 

9 person required to provide reimbursement in relation to the 

10 persons to be reimbursed and the share of the market for 

11 such substance of the person required to provide reimburse- 

12 ment in relation to the share of such market of the persojis to 

13 be reimbursed. An order under this subparagraph shall be 

14 considered final agency action, for purposes of judicial 

15 review. 



16 (C) For purposes of this paragraph, the reimbursement 

17 period for any previously submitted data for a chemical sub- 

18 stance is a period — 

19 ' (i) beginning on the date of the termination of the 

20 prohibition, imposed under this section, on the manufac- 

21 ture or processing of such substance by the person who 

22 submitted such data to the Administrator, and 

23 (ii) ending — 

24 (I) five years after the date referred to in 

25 clause (i), or 



336 



141 

1 (II) at the expiration of a period which begins 

2 on the date referred to in claibse (i) and is equal 

3 to the period which the Administrator determines 

4 wa^ necessary to develop such data, 

5 whichever is later, 

6 (3) The requirements of subsections (a), (b), (c), and 

7 (d) do not apply with respect to the manufacturing or 

8 processing of any chemical substance which is manufactured 

9 or processed, or proposed to be manufactured or processed, 

10 only in small quantities (as defined by the Administrator by 

11 rule) solely for — 

12 (A) scientific experimentation or analysis, or 

1*^ (B) chemical research or analysis on such sub- 

14 stance or another substance, including such research or 

15 analysis for the development of a product, 

16 if all persons engaged in such experimentation, research, or 

17 analysis for a manufacturer or processor are notified ( in such 

18 form and manner as the Administrator may prescribe) of 

19 any risk to health which the manufacturer or processor has 

20 reason to believe may be associated with such chemical 

21 substance. 

22 (4) (A) The requirements of subsections (a) and (c) 

23 (1) (A) do not apply with respect to the manufacturing or 

24 processing of any chemical substance which is the same as a 

25 listed chemical substance. 



337 



142 

1 (B) For purposes of subparagraph (A), a chemical 

2 substance shall not be considered as different from a listed 

3 chemical substance solely because — 

4 (i) the proportion of the inert chemical substances 

5 which are present in the listed chemical substance is dif- 

6 ferent from the proportion of such substances present in 

7 the chemical substance being compared to the listed 

8 chemical substance; or 

9 (a) an inert listed chemical substance has been 

10 added to or deleted from the chemical substance being 

11 compared. 

12 (C) For purposes of this paragraph — 

IS (i) the term ''inert chemical substance' means a 

1^ chemical substance which when combined with other 

1^ chemical substances to produce another chemical sub- 

1^ stance does not react chemically with such other chemi- 
cal substances; and 

(a) the term "listed chemical substance" means a 

1^ chemical substance included in the list compiled and 

2^ published under section 8(b). 

21 (5) The Administrator may, upon application, by 

22 rule exempt the manufacturer of any new chemical sub- 
2S stance from all or part of the requirements of this section if 
2^ the Administrator determines that such chemical substance 
2^ will not cause or significantly contribute to an unreasonable 



338 



143 

1 risk to health or the environment. A rule under this para- 

2 graph ( and any substantive amendment to, or repeal of, such 

3 a rule) shall be promulgated in accordance with paragraphs 

4 (2) and (3) of section 6(c). 

5 (j) Definition. — For purposes of this section, the 

6 terms ^'manufacture" and " process' ' mean to manufacture 

7 or to process for commercial purposes. 

8 REGULATION OF HAZARDOUS CHEMICAL SUBSTANCES 

9 AND MIXTURES 

10 Sec. 6. ( a) Scope of Regulation.— If the Adminis- 

11 trator finds that there is a reasonable basis to conclude that 

12 the manufacture, processing, distribution in commerce, use, 

13 or disposal of a chemical substance or mixture or any com- 

14 bination of such actions causes or significantly contributes to 

15 or will cause or significantly contribute to an unreasonable 
1^ risk to health or the environment, the Administrator shall by 
1'^ rule apply to such substance or mixture one or more of the 

following requirements as is necessary to adequately protect 
1^ against such risk: 

20 (1) ^ requirement prohibiting the manufacturing, 

processing, or distribution in commerce of such substance 

22 or mixture or limiting the amount of such substance or 
mixture which may be manufactured, processed, or dis- 

24 tributed in commerce. 

(2) A requirement — 



339 



144 

1 (A) prohibiting the manufacture, processing 

2 or distribution in commerce of such substance or 

3 mixture for (i) a particular use or (ii) a particular 

4 use in a concentration in excess of a level specified 

5 by the Administrator in the rule imposing the re- 

6 quirement, or 

7 (B) limiting the amount of such substance or 

8 mixture which may be manufactured, processed, 

9 or distributed in commerce for (i) a particular use 

10 or ( ii) a particular use in a concentration in excess 

11 of a level specified by the Administrator in the rule 

12 imposing the requirement. 

io (3) A requirement that such substance or mixture 

14 or any article containing such substance or mixture be 

15 marked with or accompanied by clear and adequate 

16 warnings and instructions with respect to its use or dis- 
1*^ posal or with respect to both. The form and content of 

18 su^ih warnings and instructions shall be prescribed by 

19 the Administrator. 

20 (4) A requirement that manufacturers and proc- 

21 essors of such substance or mixture make and retain 

22 records of the processes used to manufacture or process 

23 such substance or mixture. 

24 (5) (A) A requirement regulating the manner or 

25 method of disposal of such substance or ■ mixture or 



340 



145 

1 article containing such substance or mixture by its 

2 manufacturer or processor or any other person who 

3 v^es it for commercial purposes. 

4 (B) A requirement under subparagraph (A) may 

5 not require any person to take any action which would 

6 be in violation of any law of a State or political subdivi- 

7 sion, and shall require each person subject to it to notify 

8 each State and political subdivision in which a required 

9 disposal may occur of such requirement. 

10 (6) If the rule imposes on a chemical substance 

11 or mixture a requirement described in paragraph (1) 

12 or (2), a requirement directing the manufacturer, proc- 

13 essor, or distributor in commerce of such substance or 
mixture or article containing such substance or mixture 
or directing any combination of such persons (A) to 
to give notice of such risk to processors or distributors 

^'^ in commerce of such substance, mixture, or article, or 

to both, and, to the extent reasonably ascertainable, to 
1^ any other person in possession of or exposed to such 

20 substance, mixture, or article; (B) to give public notice 

21 of such risk; or (C) to give both such notices. 

22 A requirement imposed under this subsection shall be the 

23 least burdensome requirement necessary to adequately pro- 

24 tect against the risk with respect to which the requirement 



341 



146 

1 was imposed and may be limited in application to specified 

2 geographic areas, 

3 (b) Protection Against Adulteration or Con- 

4 TAMINATION OF SUBSTANCES AND MIXTURES.— If the 

5 Administrator has good cause to believe thai a particular 

6 manufacturer or processor is manufacturing or processing a 

7 chemical substance or mixture in a manner which uninten-' 

8 tionally causes the chemical substance or mixture to cause 

9 or significantly contribute to or to be likely to cause or sig- 

10 nificantly contribute to an unreasonable risk to health or the 

11 environment — 



12 (1) the Administrator may by order require such 

13 manufacturer or processor to submit a description of 

14 the relevant quality control procedures followed in the 

15 manufacturing or processing of such chemical substance 

16 or mixture; and 

l'^ (2) if the Administrator determines after the issur 

18 ance of an order described in paragraph (1) — 

19 (A) that such quality control procedures are 

20 inadequate to prevent the chemical substance or mix- 

21 ture from causing or significantly contributing to 

22 siuih risk, the Administrator may order the manu- 

23 facturer or processor to revise such quality control 

24 procedures to the extent necessary to remedy such 

25 inadequacy; or 



342 
147 

(B) that the use of such quality control proce- 
dures has resulted in the distribution in commerce 
of chemical substances or mixtures which cause or 
significantly contribute to an unreasonable risk to 
health or the environment, the Administrator may 
order the manufacturer or processor to (i) give 
notice of such risk to processors or distributors in 
commerce of any such substance or mixture, or to 
both, and, to the extent reasonably ascertainable, to 
any other person in possession of or exposed to any 



11 such subsance, (ii) to give public notice of such 

12 risk, and (Hi) to provide such replacement or re- 

13 purchase of any such substance or mixture as is 

14 necessary to adequately protect health or the en- 

15 • vironment. 



16 A determination under subparagraph (A) or (B) of para- 

17 graph (2) shall be made on the record after opportunity for 

18 hearing in accordance with section 554 of title 5, United 

19 States Code. The manufacturer or processor subject to a 

20 requirement to replace or repurchase a chemical substance 

21 or mixture may decide whether to replace or repurchase the 

22 substance or mixture and shall take either such action in the 

23 manner prescribed by the Administrator. 

24 (c) Promulgation of Subsection (a) Rules.— 

25 (1) In promulgating any rule under subsection (a) with 



343 



148 

^ respect to a chemical substance or mixture, the Administra- 
tor shall consider all relevant factors and make findings 
with respect to — 

^ (A) the effects of such substance or mixture on 

health and the magnitude of human exposure to such 
_ substance or mixture, 

^ (B) the effects of such substance or mixture on the 

g environment and the magnitude of environmental expo- 
^ sure to such substance or mixture, 

(C) the benefits of such substance or mixture for 
various uses and the availability of other substances or 

j2 mixtures for such uses, and 

(D) the reasonably ascertainable economic conse- 
24 quences of such rule taking into account the impact on 
j5 small business. 

If the Administrator determines that a risk to health or the 
17 environment could be eliminated or reduced to a sufficient 
Ig extent by actions taken under another Federal law (or 

19 laws) administered in whole or in part by the Administra- 

20 ihe Administrator may not promulgate a rule under 

21 subsection (a) to protect against such risk unless the Admin- 

22 istrator makes a finding that it is in the public interest 

23 to protect against such risk under such rule taking into con- 

24 sideration all aspects of the risk, the authorities under this 

25 Act and such other law (or laws) to enforce actions taken 



344 



149 

1 under this Act or such law (or laws) to protect against such 

2 risk, a comparison of the estimated costs of complying with 

3 actions taken under this Act and under such law (or laws), 

4 and the relative efficiency of actions under this Act and 

5 under such law (or laws). In the judicial review of a rule 

6 under subsection (a) the last sentence of section 19(c)(1) 

7 shall not apply with respect to the determinations and find- 

8 ings required to be made by this paragraph. 

9 (2) (A) Rules under subsection (a) shall be promul- 

10 gated pursuant to section 558 of title 5 of the United States 

11 Code; except that in promulgating any such rule (i) the 

12 Administrator shall give interested persons an opportunity 
1^ for the oral presentation of data, views, or arguments, in 
1^ addition to an opportunity to make written submissions; (ii) 
1^ a transcript shall be kept of any oral presentation; and (Hi) 

during any such oral presentation, the Administrator shall 
^''^ include an opportunity for cross-examination as provided 

in subparagraph (B). The Administrator may not promul- 
1^ gate a rule under subsection (a) respecting a chemical sub- 

20 stance or mixture unless the Administrator makes and pub- 

21 lishes with the rule the finding described in such subsection. 

22 (B) An interested person is entitled, if the Administra- 
tor determines that it is necessary to resolve disputed issues 

24 of material fact, to conduct or have conducted by the Ad- 
2*^ ministrator such cross-examination of persons as the Admin- 



I 



345 



150 

1 istrator determines (i) to be appropriate in view of any 

2 need for expedition, the nature of the issues involved, and 

3 the number of participants and the nature of their interests, 

4 and ( ii) to be required for a full and true disclosure with 

5 respect to such issues. 

6 (C)(i) If the Administrator determines that a group 

7 of persons, each of whom would but for this subparagraph 

8 be entitled to conduct (or have conducted) cross-examina- 

9 tion, has the same or similar interests in a proceeding, the 

10 Administrator may (I) conduct cross-examination on behalf 

11 of such group, or (II) require such group to designate a 

12 single representative of such interests for purposes of con- 

13 ducting cross-examination in such proceeding and such rep- 
resentative shall, except as provided in clause (ii), conduct 
such cross-examination. If such group cannot agree upon a 
single representative for such purposes, the Administrator 
may limit the representation of such interests for such 

-IQ 

purposes. 

( ii) When any person who is a member of a group with 
respect to which the Administrator has made a determina- 
tion under clause (i) is unable to agree upon group repre- 

22 

sentation with the other members of the group, then such 

23 

person shall not be denied under the authority of such clause 

^ the opportunity to conduct (or have conducted) cross-exami- 
25 

nation as to issues affecting the person's particular interests 



79-313 O - 77 - 23 



346 



151 

1 if (I) the person satisfies the Administrator that the person 

2 has made a reasonable and good faith effort to reach agree- 

3 ment upon group representation with the other members of 

4 the group and (II) the Administrator determines that there 

5 are substantial and relevant issues which are not adequately 

6 presented by the group representative. 

7 (D) The Administrator may issue procedural rules 

8 for the conduct of any oral presentation (including cross- 

9 examination) under this paragraph and may impose such 

10 reasonable time limits on each persons oral presentations 

11 authorized by this paragraph as may be appropriate in view 

12 of any need for expeditioUj the nature of the issues involvedy 

13 and the number of participants and the nature of their 
interests. 

(E) In the judicial review of a ride under subsection 
(a) the last sentence of section 19(c)(1) shall not apply to 
^'^ any determination of the Administrator under this paragraph. 
^® (3) (A) The Administrator may, pursuant to rules pre- 
1^ scribed by it, provide compensation for reasonable attorneys^ 
2^ fees, expert witness fees, and other costs of partimpating in a 
rulemaking proceeding for the promulgation of a rule under 
subsection (a) to any person who represents an interest 
which will substantially contribute to a fair determination of 
^ the issues to be resolved in the proceeding taking into account 
the number and complexity of such issues and whether rep- 



347 



152 

1 resentation of such interest will contribute to widespread 

2 public participation in the proceeding and representation 

3 of a fair balance of interests for the resolution of such issues 

4 if— 

5 (i) the economic interest of such person is small in 

6 comparison to the costs of effective participation in the 

7 proceeding by such person^ or 

8 (ii) such person demonstrates to the satisfaction of 

9 the Administrator that such person does not have suffi- 

10 dent resources adequately to participate in the proceed- 

11 ing in the absence of compensation under this subpara- 

12 graph. 

13 In determining whether compensation should be provided 
to a person under this subparagraph and the amount of such 
compensation, the Administrator shall take into account the 

1fi 

financial burden which will be incurred by such person in 

17 

participating in the rulemaking proceeding. 

(B) The aggregate amount of compensation paid under 
this paragraph in any fiscal year to all persons who, in rule- 
making proceedings in which they receive compensation, are 

21 

persons who either — 

(i) would be regulated by the proposed rule, or 

23 J 

(ii) represent persons who would be so regulated, 

^ may not exceed 25 per centum of the aggregate amount 



348 



153 

1 paid as compensation under this paragraph to all persons 

2 in such fiscal year. 

3 (4) Paragraphs (1), (2), and (3) of this subsection 

4 apply to the promulgation of a rule repealing, or making 

5 a substantive amendment to, a rule promulgated under sub- 

6 section (a). 

7 (d) Effective Date.—(1) The Administrator shall 

8 specify in any rule under subsection (a) the date on which it 

9 shall take effect, which date shall be as soon as feasible. 

10 (2) (A) The Administrator may declare a proposed 

11 rule under subsection (a) to be effective upon its publication 

12 in the Federal Register and until the effective date of final 

13 action taken, in accordance with subparagraph (B), respect- 
ing such rule if — 

(i) the Administrator determines that — 

(I) the manufacture, processing, distribution 

11 

in commerce, use, or disposal of the chemical sub- 
stance or mixture subject to such proposed rule or 
any combination of such activities is likely to result 
in an unreasonable risk of serious or widespread 
harm to health or the environment before such effec- 

22 

tive date; and 

(II) making such proposed rule so effective 
^ is necessary to protect the public interest; and 



349 



154 

2 (a) in the case of a proposed rule to prohibit the 

2 manufacture, processing, or distribution of a chemical 

3 substance or mixture because of the risk determined un- 

4 der clause (i) (I), a court has in an action under section 

5 7 granted relief with respect to such risk associated with 

6 such substance or mixture. 

7 (B) If the Administrator makes a proposed rule effec- 

8 tive upon its publication in the Federal Register, the Ad- 

9 ministrator shall, as expeditiously as possible, give interested 

10 persons prompt notice of such action, provide reasonable 

11 opportunity, in accordance with paragraphs (2) and (3) 

12 of subsection (c), for a hearing on such rule, and either 

13 affirm such rule (as proposed or with modifications) or re- 

14 voke it; and if such a hearing is requested, the Administrator 

15 shall commence the hearing within five days from the date 

16 such request is made unless the Administrator and the person 

17 making the request agree upon a later date for the hearing 

18 to begin, and after the hearing is concluded the Administrator 

19 shall, within ten days of the conclusion of the hearing, either 

20 affirm such rule ( as proposed or with modifications) or re- 

21 voke it. 

22 IMMINENT HAZARDS 

23 Sec. 7. (a) Actions Authorized and Required.— 

24 (1) The Administrator may file an action in a district court 

25 of the United States — 



350 
155 

1 (A) for seizure of an imminently hazardous chemi- 

2 cal substance or mixture or any article containing such 

3 a substance or mixture, 

4 (B) for relief (as authorized by subsection (b) ) 

5 against any person who manufactures, processes, or 

6 distributes in commerce an imminently hazardous chemi- 

7 cal substance or mixture or any article containing such 

8 a substance or mixture, or 

9 (C) for both such seizure and relief. 

10 An action may be filed under this paragraph notwithstand- 

11 ing the existence of a rule under section 4, 5, or 6, and not- 

12 withstanding the pendency of any administrative or judicial 
1^ proceeding under any provision of this Act. 

1*^ (2) If the Administrator has not made a rule under 

1^ section 6(a) imm£diately effective (as authorized by sub- 
1^ section 6(d) (2) (A) (i) ) with respect to an imminently haz- 
1'^ ardous chemical substance or mixture, the Administrator 

shall file in a district court of the United States with respect 
1^ to such substance or mixture or article containing such sub- 

stance or mixture an action described in subparagraph (A), 

(B), or (C ) or paragraph (1 ) . 

(b) Jurisdiction of Court.— (1) The district court 

of the United States in which an action under subsection ( a) 
^ is broug}it shall have jurisdiction to grant such temporary 

or permanent relief as may be necessary to protect health 



351 



156 

1 or the environment from the unreasonable risk associated 

2 with the chemical substance^ mixture, or article involved in 

3 such action. 

4 (2) In the case of an action under subsection (a) 

5 brought against a person who manufactures, processes, or 

6 distributes in commerce a chemical substance or mixture or 

7 an article containing a chemical substance or mixture, the 

8 relief authorized by paragraph (1) may include the issuance 

9 of a mandatory order requiring (A) in the case of purchasers 

10 of such substance, mixture, or article known to the defendant, 

11 notification to such purchasers of the risk associated with it; 

12 (B) public notice of such risk; (C) recall; (D) the re- 

13 placement or repurchase of such substance, mixture, or 

14 article; or (E) any combination of the actions described 

15 in the preceding clauses. 

16 (3) In the case of an action under subsection (a) against 

17 a chemical substance, mixture, or article, such substance, 

18 mixture, or article may be proceeded against by process of 

19 libel for its seizure and condemnation. Proceedings in such 

20 an action shall conform as nearly as possible to proceedings 

21 in rem in admiralty. 

22 (c) Venue and Consolidation.— (1) (A) An action 

23 under subsection (a) against a person who manufactures, 

24 processes, or distributes a chemical substance or mixture or 

25 an article containing a chemical substance or mixture may be 



352 
157 

1 brought in the United States District Court for the District 

2 of Columbia or for any judicial district in which any of the 

3 defendants is founds resides^ or transacts business; and 

4 process in such an action may be served on a defendant in 

5 any other district in which such defendant resides or may 

6 be found. An action under subsection (a) against a chemical 

7 substancCy mixture^ or article may be brought in any United 

8 States district court within the jurisdiction of which the sub- 

9 stance, mixture, or article is found. 

10 (B) In determining the judicial district in which an 

11 action may be brought under subsection (a) in instances in 

12 which such action may be brought in more than one judicial 

13 district, the Administrator shall take into account the ^con- 

14 venience of the parties. 

15 (C) Subpenas requiring attendance of witnesses in an 

16 action brought under subsection ( a) may run into any judi- 
1'^ cial district. 

18 (2) Whenever proceedings under subsection (a) in- 

19 volving identical chemical substances, mixtures, or articles 

20 are pending in courts in two or more judicial districts, they 

21 shall be consolidated for trial by order of any such court 

22 upon application reasonably made by any party in interest, 

23 upon notice to all parties in interest. 

24 (d) Action Under Section 6.— Where appropriate, 

25 concurrently with the filing of an action under subsection ( a) 



353 



158 

1 or as soon thereafter as may be practicable, the Administrator 

2 shall initiate a proceeding for the promulgation of a rule 

3 under section 6(a). 

4 (c) Representation. — Notwithstanding any other 

5 provision of law, in any action under subsection (a), the 

6 Administrator may direct attorneys of the Environmental 

7 Protection Agency to appear and represent the Administra- 

8 tor in such an action. 

9 (f) Definition. — For purposes of subsection (a), the 

10 term ''imminently hazardous chemical substance or mixture^^ 

11 means a chemical substance or mixture which causes or 

12 significantly contributes to an imminent and unreasonable 

13 risk of serious or widespread harm to health or the environ- 
1^ ment. Such a risk to health or the environment shall be con- 
1^ sidered imminent if it is shown that the manufacture, proc- 
1^ essing, distribution in commerce, use, or disposal of the 

chemical substance or mixture or any combination of such 
actions is likely to result in such harm to health or the envi- 

1^ ronment before a final rule under section 6 can protect 

2^ against such risk. 

21 REPORTING AND RETENTION OF INFORMATION 

^ Sec. 8. (a) Reports. — (1) The Administrator shall 

promulgate rules under which — 

^ (A) each person (other than a small manufacturer 

^ or processor) who manufactures or processes or proposes 



354 



159 

1 to manufacture or process a chemical substance (other 

2 than a chemical substance described in subparagraph 

3 ii) ) shall maintain such records^ and shall submit 

4 to the Administrator such reports, as the Administrator 

5 may reasonably require, and 

6 ( B) each person ( other than a small manufacturer 

7 or processor) who manufactures or processes or proposes 

8 to manufacture or process — 

9 (i) a mixture J or 

(ii) a chemical substance in small quantities 
•^^ (as defined by the Administrator by rule) solely for 

^2 scientific experimentation or analysis or for chemical 

1^ research or analysis on such susbtance or another 

substance, including such research or analysis for 
the development of a product, 
shall maintain records and submit to the Administrator 
^'^ reports but only to the extent the Administrator deter- 
mines the maintenance of records or submission of 
reports, or both, is necessary for the effective enforcement 
^ of this Act. 

The Administrator may not require in a rule promulgated 
under this paragraph the maintenance of records or the sub- 
mission of reports with respect to changes in the proportions 
^ of the components of a mixture unless the Administrator finds 
^ that the maintenance of such records or the. submission of such 



355 



160 

1 reports^ or both, is necessary for the effective enforcement of 

2 this Act. For purposes of the compilation of the list of chemi- 

3 cal substances required under subsection (b), the Administra- 

4 tor shall promulgate rules pursuant to this subsection not later 

5 than one hundred and eighty days after the effective date of 

6 this Act. 

7 (2) The Administrator may require under paragraph • 

8 (1) reporting with respect to the following: 

9 (A) The common or trade name, the chemical 

10 identity, and the molecular structure of each chemical 

11 substance or mixture for which such a report is required, 

12 insofar as known to the person making the report or 

13 insofar as reasonably ascertainable. 

14 (B) The categories or proposed categories of use 

15 of each such substance or mixture, insofar as known to 

16 the person making the report or insofar a^ reasonably 

17 ascertainable. 

18 (C) Reasonable estimates of the amount of each 

19 substance and mixture to be manufactured or processed 

20 and, insofar as known to the person making the report 

21 or insofar as reasonably ascertainable, a reasonable esti- 

22 mate of the amount of each such substance and mixture 

23 to be manufactured or processed for each of its categories 

24 or proposed categories of use. 

25 (D) A description of the byproducts resulting from 



356 



161 

1 the manufacture^ processing, use, or disposal of each such 

2 substance or mixture, insofar as known to the person 

3 making the report or insofar as reasonably ascertainable. 

4 (E) All existing data concerning the adverse en- 

5 vironmental and health effects of such substance or mix- 

6 ture, insofar as known to the person making the report. 

7 (F) Estimates of the number of persons who will 

8 be exposed to such substance or mixture in their places 

9 of employment and the duration of such exposure, inso- 

10 far as known to the person making the report. 

11 To the extent feasible the Administration shall not require 

12 under paragraph (1) unnecessary or duplicate reporting. 

13 (3)(A)(i) The Administrator may by rule require a 

14 small manufacturer or processor of a chemical substance to 

15 submit to the Administrator such information respecting the 
1^ chemical substance as the Administrator may require for 
l'^ publication of the first list of chemical substances required 
1^ by subsection (b). 

19 (ii) The Administrator may by rule require a small 

20 manufacturer or processor of a chemical substance or mix- 

21 ture — 

22 (ij subject to a rule proposed or promulgated under 

23 section 4, 5(c) , 5(g), or 6, or 

24 (II) with respect to which relief has been granted 
2^ pursuant to a civil action brought under section 7, 



357 



162 

1 to maintain such records on such substance or mixture, and 

2 to submit to the Administrator such reports on such sub- 

3 stance or mixture, as the Administrator may reasonably 

4 require. A rule under this clause requiring reporting may 

5 require reporting with respect to the matters referred to 

6 in paragraph ( 2) . 

7 (B) The Administrator, after consultation with the Ad- 

8 ministrator of the Small Business Administration, shall by 

9 rule prescribe standards for determining the manufacturers 
1^ and processors which qualify as small manufacturers and 

11 processors for purposes of this paragraph and paragraph 

12 (1). 

1^ (b) Inventory. — (1) The Administrator shall com- 
14 

pile, keep current, and publish a list of each chemical sub- 

15 . . 

stance which is manufactured or processed in the United 

16 

States. Such list shall at least include each chemical sub- 

17 

stance which any person reports, under section 5 or sub- 

18 

section (a) of this section, is manufactured or processed in 

19 

the United States or was manufactured or processed in the 

20 

United States within three years before the effective date of 

21 

the rules promulgated pursuant to the last sentence of suh- 

22 

section (a) (1) . In the case of a chemical substance for which 

23 

a notice is submitted in accordance with section 5, such 

24 

chemical substance shall be included in such list as of the 



358 



163 

1 earliest date (as determined by the Administrator) on which 

2 such substance was manufactured or processed in the United 

3 States. The Administrator shall first publish such a list not 

4 later than one year after the effective date of this Act, The 

5 Administrator shall not include in such list any chemical 

6 substance which is manufactured or processed only in small 

7 quantities (as defined by the Administrator by rule) solely 

8 for scientific experimentation or analysis or for chemical 

9 research or analysis on such substance or another substance, 

10 including such research or analysis for the development of a 

11 product. 

12 (2) To the extent consistent with the purposes of this 

13 Act, the Administrator may, in lieu of listing, pursuant to 
paragraph (1), a chemical substance individually, list a 
category of chemical substances in which such substance is 
included. 

(c) Records, —Any person who manufactures, proc- 
esses, or distributes in commerce or proposes to manufacture, 
process, or distribute in commerce any chemical substance or 
mixture shall, as required by the Administrator by rule, 
maintain records of adverse reactions to health or the envi- 
ronment alleged to have been caused by the substance or 
mixture. In such a rule the Administrator may require that — 
^ (1) records of adverse reactions to the health of 



359 



164 

1 employees he retained for a period of not more than fifty 

2 years from the date such reactions were first reported to 

3 or known by the person maintaining such records^ and 

4 (2) any other record be retained for a period of 

5 not more than five years from the date the information 

6 contained in the record was first reported to or known by 

7 the person maintaining the record, 

8 Records required to be maintained under this subsection may 

9 include records of consumer allegations of personal injury 

10 or harm to health, reports of occupational disease or injury, 

11 and reports or complaints of injury to the environment 

12 submitted to the manufacturer, processor, or distributor in 

13 commerce by individuals or governmental agencies. Upon 

14 request of an officer or employee duly designated by the Ad- 

15 ministrator, each person who is required to maintain records 
1^ under this subsection shall permit the inspection of such 
1'^ records and shall submit copies of such records. 

18 (d) Health and Safety Studies. — The Adminis- 

19 trator shqll promulgate rules under which the Administrator 

20 may require any person who manufactures, processes, or dis- 

21 tinhutes in commerce or who proposes to manufacture, proc- 

22 ess, or distribute in commerce any chemical substance or mix- 

23 ture (or with respect to paragraph (2), any person who 
^ has possession of a study) to submit to the Administrator — 

(1) lists of health and safety studies conducted or 



360 



165 

1 initiated by or for such person at any time or known 

2 to such person; and 

3 (2) copies of any such studies appearing on a list 

4 submitted pursuant to paragraph (1) or (2), or other- 

5 wise known by such person, 

6 (e) Notice to Administrator of Unreasonable 

7 Risks, — Any person who manufactures, processes, or dis- 

8 tributes in commerce a chemical substance or mixture and 

9 who obtains information which reasonably supports the con- 

10 elusion that such substance or mixture causes or significantly 

11 contributes to a substantial risk to health or the environment 

12 shall immediately inform the Administrator of such infor- 

13 mation unless such person has actual knowledge that the 
1^ Administrator has been adequately informed of such in- 
1^ formation, 

(f) Definitions. — For purposes of this section, the 
^'^ terms ^^manufacture'' and process" mean manufacture or 
process for commercial purposes, 

19 RELATIONSHIP TO OTHER FEDERAL LAWS 

20 Sec, 9, (a) Laws Not Administered by the Ad- 

21 MINISTRATOR. — (1) If the Administrator has reason to be- 
2^ lieve that the manufacture, processing, distribution in com- 

merce, v^e, or disposal of a chemical substance or mixture or 
^ any combination of such actions causes or significantly con- 
tributes to or is likely to cause or significantly contribute to 



361 



166 

1 an unreasonable risk to health or the environment and deter- 

2 mines that such risk may be prevented or reduced to a suffi- 

3 dent extent by action taken under a Federal law not adminis- 

4 tered by the Administrator, the Administrator shall submit to 

5 the agency which administers such law a report which de- 

6 scribes such risk and includes in such description a specifica- 

7 tion of the activity or combination of activities which the. 

8 Administrator has reason to believe so causes or contributes 

9 to such risk. Such report shall also request such agency — 



10 (A)(i) to determine if the risk described in such 

11 report may be prevented or reduced to a sufficient extent 

12 by action taken under such law, and 

13 (ii) if the agency determines that such risk may be 

14 so prevented or reduced, to issue an order declaring 

15 whether or not the activity or combination of activities 

16 specified in the description of such risk causes or signifi- 

17 canity contributes to such risk; and 

18 (B) to report such determination and order to the 

19 Administrator, 



20 Any report of the Administrator shall include a detailed 

21 statement of the information on which it is based and shall 

22 be published in the Federal Register. The agency receiving 

23 a request under such a report shall make the requested de- 

24 termination, issue the requested order, and make the re- 

25 quested report within such time as the Administrator specifies 



79-313 - 77 - 24 



362 



167 

1 in the request, but such time specified may not be less than 

2 ninety days from the date the request was made. The report 

3 of an agency in response to a request of the Administrator 

4 shall be accompanied by a detailed statement of the findings 

5 and conclusions of the agency respecting the order and de- 

6 termination requested to be made and shall be published in 

7 the Federal Register, 



8 (2) If the Administrator makes a report under para- 

9 graph (1) with respect to a chemical substance or mixture 

10 and the agency to which such report was made either — 

11 (A) issues an order declaring that the activity or 

12 combination of activities specified in the description of the 

13 risk described in the report does not cause or significantly 

14 contribute to the risk described in the report, or 

15 (B) initiates, within ninety days of the publication 

16 in the Federal Register of the report of the agenxiy under 

17 paragraph (1) in response to the Administrator's report, 

18 action under the law (or laws) administered by such 

19 agency to protect against such risk, 

20 the Administrator may not take any action under section 6 

21 or 7 with respect to such risk. 

22 (S) If the Administrator has initiated action under sec- 

23 Hon 6 or 7 with respect to a risk associated with a chemical 

24 substance or mixture which was the subject of a report made 

25 to an agency under paragraph (1), such agency shall before 



363 



168 

1 taking action under the law (or laws) administered by it to 

2 protect against such risk consult with the Administrator for 

3 the purpose of avoiding duplication of Federal action against 

4 such risk. 

5 (h) Laws Administered by the Administrator,— 

6 The Administrator shall coordinate actions taken under this 

7 Act with actions taken under other Federal laws administered 

8 in whole or in part by the Administrator. If a risk to health 

9 or the environment associated with a chemical substance or 

10 mixture could be eliminated or reduced to a sufficient extent 

11 by actions taken under the authorities contained in such other 

12 Federal laws, the Administrator shall use such authorities to 

13 protect against such risk unless the Administrator determines 

14 that it is in the public interest to protect against such risk by 

15 actions taken under this Act. This subsection shall not be 

16 construed to relieve the Administrator of any requirement 

17 imposed on the Administrator by such other Federal laws. 

18 (c) Occupational Safety and Health.— In exer- 

19 dsing any authority under this Act, the Administrator shall 

20 noty for purposes of section 4(b)(1) of the Occupational 

21 Safety and Health Act of 1970, be deemed to be exercising 

22 statutory authority to prescribe or enforce standards or regu- 

23 lations affecting occupational safety and health. 

24 (d) Coordination. — In administering this Act, the 

25 Administrator shall consult and coordinate with the Secre- 



364 
169 

1 tary of Health, Education, and Welfare and the heads of 

2 any other appropriate Federal executive department or 

3 agency, any relevant independent regulatory agency, and 

4 any other appropriate instrumentality of the Federal Gov- 

5 ernment for the purpose of achieving the maximum enforce- 

6 ment of this Act while imposing the least burdens of dupli- 

7 cative requirements on those subject to the Act and for other 

8 purposes. The Administrator shall report annually to the 

9 Congress on actions taken to coordinate with such other Fed- 

10 eral departments, agencies, or instrumentalities, and on 

11 actions taken to coordinate the authority under this Act with 

12 the authority granted under other Acts referred to in sub- 

13 section (b). 

14 RESEARCH, COLLECTION, DISSEMINATION, AND 

15 UTILIZATION OF DATA 

16 Sec. 10. (a) Authority. — The Administrator shall, in 

17 consultation and cooperation with the Secretary of Health, 

18 Education, and Welfare and with other heads of appropriate 

19 departments and agencies, conduct such research and moni- 

20 toring as is necessary to carry out the purposes of this Act. 

21 The Administrator may enter into contracts and may make 

22 grants for such research and monitoring. Contracts may be 

23 entered into under this subsection without regard to sections 

24 3648 and 8709 of the Revised Statutes (31 U.S.C. 529, 41 

25 U.S.C.5). 



365 



170 

1 (b) Data Systems.— (1) The Administrator shall 

2 establish, administer, and be responsible for the continuing 

3 activities of an interagency committee which will design, 

4 establish, and coordinate an efficient and effective system, 

5 within the Environmental Protection Agency, for the collec- 

6 tion, dissemination to other Federal departments and agen- 

7 cies, and use of data submitted to the Administrator under this 

8 Act. 

9 (2) (A) The Administrator shall, in consultation with 

10 the Secretary of Health, Education, and Welfare and other 

11 heads of appropriate departments and agencies design, estab- 

12 lish, and coordinate an efficient and effective system for the 

13 retrieval of toxicological and other scientific data which could 

be useful to the Administrator in carrying out the purposes 

of this Act. Systematized retrieval shall be developed for use 

by all Federal and other departments and agencies with re- 
17 ... . 

sponsibilities in the area of regulation or study of chemical 

18 

substances and mixtures and their effect on health or the 
environment. 

20 

(B) The Administrator, in consultation with the Secre- 

21 

tary of Health, Education, and Welfare, is authorized to 

22 

make grants and enter into contracts for the development of 

23 

a data retrieval system described in subpargaraph (A). Con- 

24 

tracts may be entered into under this subparagraph without 

25 

regard to sections 3648 and 3709 of the Revised Statutes 
(31 U.S.C. 529, 41 U.S.C. 5). 



366 



171 

1 INSPECTIONS 

2 Sec. 11. (a) In General. — For purposes of enforce- 

3 ment of this Act the Administrator, or any representative of 

4 the Administrator, duly designated by the Administrator, may 

5 inspect any establishment, facility, or other premises in which 

6 chemical substances or mixtures are manufactured, processed, 

7 stored, or held before or after their distribution in commerce 

8 and any conveyance being used to transport chemical sub- 

9 stances or mixtures in connection with distribution in com- 

10 merce. Such an inspection may only be made upon presenting 

11 appropriate credentials and a written notice to the owner, 

12 operator, or agent in charge of the premises or conveyance 
1^ to be inspected. A separate notice shall be given for each such 
1^ inspection, but a notice shall not be required for each entry 
1^' made during the period covered by the inspection. Each 

such inspection shall be commenced and completed with rea- 
sonable promptness and shall be conducted at reasonable times, 
within reasonable limits, and in a reasonable manner. 
1^ (b) Scope. — ( 1 ) Except as provided in paragraph ( 2) , 

20 an inspection under subsection (a) shall extend to all things 

21 within the premises or conveyance inspected (including rec- 

22 ords, files, papers, processes, controls, and facilities) bearing 
on whether the requirements of this Act applicable to the 

^ chemical substances or mixtures within such premises or con- 
veyance have been complied with. 



367 



172 

1 (2) No inspection under subsection (a) shall extend to — 

2 (A) financial data, 

3 (B) sales data other than shipment data, 

4 (C) pricing data, 

5 (D) personnel data, or 

6 (E) research data (other than research data re- 

7 quired by this Act) , 

8 unless the nature and extent of such data are described with 

9 reasonable specificity in the written notice required by sub- 

10 section ( a) for such inspection. 

11 EXPORTS 

12 Sec, 12. (a) General. — (1) Except as provided in 

13 paragraph (2) and subsection (b), this Act (other than 
1^ section 8) shall not apply to any chemical substance, mix- 

ture, or an article containing a chemical substance or mix- 
16 ture if— 

■^'^ (A) it can be shown that such substance, mixture, 

or article is being manufactured, processed, sold, or held 
1^ for sale, for export from the United States, unless such 

20 substance, mixture, or article was, in fact, manufactured, 

21 processed, or distributed in commerce, for use in the 
United States, and 

(B) such substance, mixture, or article when dis- 
^ tributed in commerce, or any container in which it is en- 
^ closed when so distributed, bears a stamp or label stating 



368 



173 

1 that such substance, mixture^ or article is intended for 

2 export. 

3 (2) Paragraph (1) shall not apply to any chemical sub- 

4 stance, mixture, or article if the Administrator finds that the 

5 substance, mixture, or article will cause or significantly con- 

6 tribute to an unreasonable risk to health within the United 

7 States or to the environment of the United States. The 

8 Administrator may require, under section 4, testing of a 

9 chemical substance or mixture exempted from this Act by 
1^ paragraph (1) to determine whether or not such substance 

11 or mixture causes or significantly contributes to an unreason- 

12 able risk to health within the United States or to the environ- 
1^ ment of the United States. 

(b) Notice. — (1) If any person exports or intends 
to export to a foreign country a chemical substance or mixture 
for which the submission of data is required under section 4 
or 5(d), such person shall notify the Administrator of such 
exportation or intent to export and the Administrator shall 
1^ furnish to the government of such country notice of the avail- 
2^ ability of the data submitted to the Administrator under such 
section for such substance or mixture. 
' (2) If any person exports or intends to export to a for- 
eign country a chemical substance or mixture for which a rule 
^ hm been proposed or promulgated under section 5 or 6, or 
with respect to which an action is pending, or relief has been 



369 



174 

1 granted under section 7, such person shall notify the Ad- 

2 ministrator of such exportation or intent to export and the 

3 Administrator shall furnish to the government of such country 

4 notice of such rule, action, or relief. 

5 ENTRY INTO CUSTOMS TERRITORY OF THE UNITED 

6 STATES 

7 Sec. 13. (a) In General.— (1) The Secretary of the 

8 Treasury shall refuse entry into the customs territory of the 

9 U nited States ( as defined in general headnote 2 to the Tariff 

10 Schedules of the United States) of any chemical substance, 

11 mixture, or article containing a chemical substance or mix- 

12 ture offered for entry if — 

13 (A) it fails to comply with any rule in effect under 

14 this Act, or 

15 (B) it is offered for entry in violation of section 5, 

16 a rule or order under section 5 or 6, or an order issued 
1*^ in an action brought under section 5 or 7. 

18 (2) If a chemical substance, mixture, or article is 

19 refused entry under paragraph (1), the Secretary of the 

20 Treasury shall notify the consignee of such entry refusal, 

21 shall not release it to the consignee, and shall cause its 

22 disposal or, storage (under such rules as the Secre- 

23 tary of the Treasury may prescribe) if it has not been ex- 

24 ported by the consignee within ninety days from the date of 

25 receipt of notice of such refusal, except that the Secre- 



370 



175 

1 tary of the Treasury may, pending a review by the Admin- 

2 istrator of the entry refusal, release to the consignee such 

3 substance, mixture, or article on execution of bond for the 

4 amount of the full invoice of such siLbsiance, mixture, or 

5 article ( as such value is set forth in the customs entry ) , 

6 together with the duty thereon. On failure to return such 

7 substance, mixture, or article for any cause to the custody 

8 of the Secretary of the Treasury when demanded, such 

9 consignee shall be liable to the United States for liquidated 

10 damages equal to the full amount of such bond. All charges 

11 for storage, cartage, and labor on substances, mixtures, or 

12 articles which are refused entry or release under this sec- 

13 tion shall be paid by the owner or consignee, and in de- 

14 fault of such payment shall constitute a lien against any 

15 future entry made by such owner or consignee. 

1^ (b) Rules. — The Secretary of the Treasury, after 

17 consultation with the Administrator, shall issue rules for 

18 the enforcement of subsection (a) of this section. 

19 DISCLOSURE OF DATA 

20 Sec. 14. (a) In General. — Except as provided by 

21 subsection (b), any information reported to, or otherwise 

22 obtained by, the Administrator (or any representative of 

23 the Administrator) under this Act, which is exempt from 

24 disclosure pursuant to subsection (a) of section 552 of 

25 title 5, United States Code, by reason of subsection (b) 



371 



176 

1 (4) of such section, shall not be disclosed by the Admin- 

2 istrator or by any officer or employee of the United States, 

3 except that such information may be disclosed — 

4 (1) to officers and employees of the United States — 

5 (A) in connection with their official duties un- 

6 der laws for the protection of health or the environ- 

7 ment, or 

8 (B) for specific law enforcement purposes; 

9 (2) to contractors with the United States and 

10 employees of such contractors if in the opinion of the 

11 Administrator such disclosure is necessary for the satis- 

12 factory performance by the contractor of a contract 
1^ with the United States entered into on or after the 

effective date of this Act for the performance of work 
in connection with this Act; or 

(3) when relevant in any proceeding under this 

17 

Act, except that disclosure in such a proceeding shall 

1ft 

be made in such manner as to preserve confidentiality 



(b) Data From Health and Safety Studies.— 
(1) Subsection (a) does not prohibit the disclosure of — 

(A) any health and safety study submitted under 
this Act with respect to — 

(i) any chemical substance or mixture which 



372 
177 

1 on the date the study is to be disclosed has been 

2 offered for commercial distribution, or 

3 (ii) any chemical substance or mixture for 

4 which testing is required under section 4 or for 

5 which notification is required under section 5, and 

6 (B) any data reported to, or otherwise obtained 
^ by the Administrator from a health and safety study 
8 which relates to a chemical substance or mixture de- 
^ scribed in clause ( i) or (ii) of subparagraph (A). 

This paragraph does not authorize the release of data which 
discloses processes used in the manufacturing or processing 
•^^ of a chemical substance or mixture or, in the case of a mix- 
ture, the release of data disclosing the portion of the mixture 
comprised by any of the chemical substances in the mixture. 

(2) If a request is made to the Administrator under sub- 
section (a) of section 552 of title 5, United States Code, for 

17 

information which is described in the first sentence of para- 

18 

graph (1) and which is not information described in the 
second sentence of such paragraph, the Administrator may 
not deny such request on the basis of subsection (b)(3) or 

21 

(b)(4) of such section. 

(c) Designation of Confidential Data; Dis- 

23 

putes. — (1) In submitting data under this Act, a person 

24 

may (A) designate the data which the person believes is 
entitled to confidential treatment under subsection (a), and 



373 



178 

1 (B) submit such designated data separately from other data 

2 submitted under this Act. 

3 (2) If the Administrator proposes to release for inspec- 

4 tion data which has been designated under paragraph (1) 

5 (A), the Administrator shall notify, in writing and by certi- 

6 fied mail, the person who submitted such data of the intent 

7 to release such data. If the release of such data is to be made 

8 pursuant to a request made under section 552 ( a) of title 5, 

9 United States Code, such notice shall be given immediately 

10 upon approval of such request by the Administrator. The 

11 Administrator may not release such data until the expira- 

12 tion of thirty days after the person submitting such data has 

13 received the notice required by this paragraph. 

14 (d) Criminal Penalty for Wrongful Disclo- 
1^ SURE. — (1) Any officer or employee of the United States 
1^ or former officer or employee of the United States, who by 
-^-'^ virtue of such employment or official position has obtained 
1^ possession of, or has access to, material the disclosure of which 
19 prohibited by subsection (a), and who knowing that dis- 

closure of such material is prohibited by such subsection, will- 

^1 fully discloses the material in any manner to any person not 

^ entitled to receive it, shall be guilty of a misdemeanor and 

no 

fined not more than $5,000 or imprisoned for not more than 

^ one year, or both. Section 1905 of title 18, United States 



374 



179 

1 Code, does not apply with respect to the publishing, divulging, 

2 disclosure, or making known of, or making available, infor- 

3 mation reported or otherwise obtained under this Act. 

4 (2) For the purposes of paragraph (1), any contractor 

5 with the United States who is furnished information as 

6 authorized by subsection (a)(2), and any employee of any 

7 such contractor, shall be considered to be an employee of the 

8 United States. 

9 (e) Access by Congress. — Notwithstanding any 

10 limitation contained in this section or any other provision of 

11 law, all information reported to or otherwise obtained by the 

12 Administrator (or any representative of the Administrator) 

13 under this Act shall be made available, upon written request 
1^ of any duly authorized committee of the Congress, to such 
1^ committee. 

1^ PROHIBITED ACTS 

■^'^ Sec. 15. It shall be unlawful for any person to — 

1^ (1) fail or refuse to comply with (A) any rule or 

1^ order promulgated or issued under section 4, (B) any 

20 requirement prescribed by section 5, or (C) any rule 

21 order promulgated under section 5 or 6; 

22 (2) use for commercial purposes a chemical sub- 
^ stance or mixture which such person knew or had reason 
24 to know was manufactured, processed, or distributed in 



375 



180 

1 commerce in violation of section 5, a rule or order 

2 under section 5 or 6, or an order issued in an action 

3 brought under section 5 or 7; 

4 (3) fail or refuse to (A) establish or maintain rec- 

5 ords, (B) submit reports, notices, or other information, 

6 or (C) permit access to or copying of records^ as re- 

7 quired by this Act or a rule thereunder; or 

8 (4) fail or refuse to permit entry or inspection as 

9 required by section 11 . 

10 PENALTIES 

11 Sec. 16. (a) Civil. — (1) Any person who violates 

12 a provision of section 15 of this Act shall be liable to the 

13 United States for a civil penalty in an amount not to exceed 
^' $25,000 for each such violation. Each day such a violation 

continues shall for purposes of this subsection constitute a 
separate violation of section 15. 

(2) (A) A civil penalty for a violation of section 15 
shall be assessed by the Administrator by an order made on 
the record after opportunity (provided in accordance with 
this subparagraph) for a hearing in accordance with sec- 

tion 554 of title 5, United States Code. Before issuing such 

22 • • L 

an order, the Administrator shall give written notice to the 



Administrator s proposal to issue such order and provide 



376 



181 

1 such person an opportunity to request, within fifteen days of 

2 the date the notice is received by such person, such a 

3 hearing on the order. 

4 (B) In determining the amount of a civil penalty, the 

5 Administrator shall take into account the nature, drcum- 

6 stances, extent, and gravity of the violation or violations 
'7 and, with respect to the violator, ability to pay, effect on 

8 ability to continue to do business, any history of prior such 

9 violations, the degree of culpability, and such other matters 
1^ as justice may require. 

(C) The Administrator may, in the Administrator s 
-^^ discretion, compromise, modify, or remit, with or without 
1^ conditions, any civil penalty which may be imposed under 
this subsection. The amount of such penalty, when finally 
determined, or the amount agreed upon in compromise, may 
be deducted from any sums owing by the United States to 

17 

the person charged. 

(3) Any person who requested in accordance with 
paragraph (2) (A) a hearing respecting the assessment of a 
civil penalty and who is aggrieved by an order assessing a 
civil penalty may file a petition for judicial review of such 
order with the United States Court of Appeals for the 
District of Columbia Circuit or for any other circuit in 
^ which such person resides or transacts business. Such a 



377 



182 

1 petition may only be filed within the thirty-day period be- 

2 ginning on the date the order making such assessment was 

3 issued. 

4 ('^) If any person fails to pay an assessment of a civil 

5 penalty after it has become a final order and does not file 

6 a petition for judicial review of the order in accordance 

7 with paragraph (3) or after a court in an action brought 

8 under paragraph (3) has entered final judgment in favor 

9 of the Administrator, the Attorney General shall recover the 

10 amount assessed (plus interest at currently prevailing rates 

11 from such date) in an action brought in any appropriate 

12 district court of the United States. In such an action, the 

13 validity, amount, and appropriateness of such penalty shall 

14 not be subject to review. 

15 (b) Criminal. — Any person who knowingly or will- 

16 fully violates any provision of section 15 shall, in addition 

17 to or in lieu of a civil penalty which may be imposed under 

18 subsection (a) of this section for such violation, be subject, 

19 upon conviction, to a fine of not more than $25,000 for each 

20 day of violation, or to imprisonment for not more than one 

21 year, or both. 

22 (c) Notice, Repurchase, or Replacement,— If in 

23 a proceeding for the issuance of an order under paragraph 

24 (1) to assess a civil penalty against a person the Adminis- 

25 trator determines that such person manufactured, processed, 

79-313 - 77 - 25 



378 



183 

1 or distributed in commerce a chemical substance or mixture 

2 in violation of a requirement applicable to such substance or 

3 mixture under paragraph (1) or (2) of section 6(a) or 

4 otherwise determines by order made on the record after op- 

5 portunity for agency hearing that a person has so violated 

6 such a requirement, the Administrator may, in such order, 

7 require such person (1) to give notice of the risk associated 

8 with the chemical substance or mixture subject to such require- 

9 ment to processors or distributors in commerce of such sub- 

10 stance or mixture, or to both, and, to the extent reasonably 

11 acertainable, to any other person in possession of or exposed 

12 to such substance or mixture; (2) to give public notice of 

13 such risk; (3) to either replace or repurchase such substance 
or mixture, as determined by the person (or persons) to 
whom the requirement is directed, in the manner prescribed 
by the Administrator; or (4) to take any combination of the 
actions described in the preceding clauses. 

SPECIFIC ENFORCEMENT AND SEIZURE 

1^ Sec, 17. (a) Specific Enforcement.— (1) The 

district courts of the United States shall have jurisdiction 

over civil actions to — 
^ (A) restrain any violation of section 15, 

(B) restrain any person from manufacturing or 
^ processing a chemical substance before the expiration 



379 



184 

1 of the 'period before which such manufacturing or proc- 

2 essing is prohibited under section 5, 

3 (C) restrain any person from taking any action 

4 prohibited by section 5 or by a rule or order under sec- 

5 tion 5 or 6, or 

6 (D) compel the taking of any action required by 

7 or under this Act . 

8 (2) A civil action described in paragraph (1) may be 

9 brought — 

10 (A) in the case of a civil action described in sub- 

11 paragraph (A) of such paragraph, in the United States 

12 district court for the judicial district wherein any act, 

13 omission, or transaction constituting a violation of sec- 
tion 15 occurred or wherein the defendant is found or 

15 

transacts business, or 

16 

(B) in the case of any other civil action described 

17 

in such paragraph, in the United States district court 

18 

for the judicial district wherein the defendant is found 
or transacts business. 



may be found. Subpenas requiring attendance of witnesses 
in any such action may run into any judicial district. 

(b) Seizure, — Any chemical substance or mixture 



380 



185 

1 which was manufactured, processed, or distributed in com- 

2 merce in violation of this Act or any rule or order promul- 

3 gated under this Act or any article containing such a sub- 

4 stance or mixture shall be liable to be proceeded against, by 

5 process of libel for the seizure and condemnation of such sub- 

6 stance, mixture, or article, in any district court of the United 

7 States within the jurisdiction of which such substance, mix- 

8 ture, or article is found. Such proceedings shall conform as 

9 nearly as possible to proceedings in rem in admiralty. 

10 PREEMPTION 

11 Sec. 18. (a) Effect on State Law.—(1) Except 

12 as provided in paragraph (2), nothing in this Act shall 

13 affect the authority of any State or political subdivision of 
a State to establish or continue in effect regulation of any 
chemical substance, mixture, or article containing a chemi- 

16 

cal substance or mixture. 

IT 

(2) Except as provided in subsection (b) — 

(A) if the Administrator requires by a rule pro- 
mulgated under section 4 the testing of a chemical sub- 
stance or mixture, no State or political subdivision may, 
after the effective date of such rule, establish or con- 
tinue in effect a requirement for the testing of such 
substance or mixture for purposes similar to those for 
^ which testing is required under such rule; and 



381 



186 

1 (B) if the Administrator prescribes a rule or 

2 order under section 5 or 6 of this Act (other than 

3 a rule imposing a requirement described in subsection 

4 (a)(5) of section 6) which is applicable to a chemical 

5 substance or mixture, and which is designed to protect 

6 against a risk to health or the environment associated 

7 with such substance or mixture, no State or political 

8 subdivision of a State may, after the effective date of 

9 8uch requirement, establish or continue in effect a re- 

10 quirement applicable to such substance or mixture, or 

11 an article containing such substance or mixture, and 

12 designed to protect against such risk unless such require- 

13 ment is identical to the requirement prescribed by the 

14 Administrator or unless such requirement is adopted 
1'^ under the authority of the Clean Air Act or any other 
1^ Federal law. 

1'^ (b) Exemption. — Upon application of a State or 
political subdivision of a State the Administrator may by 

19 rule exempt from subsection (a)(2), under such conditions 

20 as may be prescribed in su6h rule, a requirement of such 

21 State or political subdivision designed to protect against a 

22 risk to health or the environment associated with a chemical 
2^ substance, mixture, or article containing a chemical substance 
^ or mixture if — 

25 (±) compliance with the requirement would not 



382 
187 

1 cause the manufacturing, processing, distribution in com- 

2 merce, or use of the substance, mixture, or article to be in 

3 violation of the applicable requirement under this Act 

4 described in subsection (a) (2), and 

5 (2) the State or political subdivision requirement 

6 (A) provides a significantly higher degree of protec- 

7 tion from such risk than the requirement under this Act 

8 described in subsection (a)(2) and (B) does not, 

9 through difficulties in marketing, distribution, or other 

10 factors, unduly burden interstate commerce. 

11 JUDICIAL REVIEW 

12 Sec. 19. ( a) In General.— Not later than sixty days 

13 following the promulgation of a rule under section 4, 5, or 

14 6(a) of this Act, any person may file a petition for judicial 
1^ review of such rule with the United States Court of Appeals 
1^ for the District of Columbia Circuit or for the circuit in 
1'^ which such person resides or in which such person's principal 
1^ place of business is located. Copies of the petition shall 

19 be forthwith transmitted by the clerk of such court to the 

20 Administrator and to the Attorney General. The Adminis- 

21 trator shall transmit to the Attorney General, who shall 

22 file in the court, the record of the proceedings on which 

23 the Administrator based such rule as provided in section 
2^ 2112 of title 28, United States Code. For purposes of this 

section, the term "record'' means such rule; any transcript 



383 



188 

1 required of any oral presentation; any written submission 

2 of interested parties; and any other information which the 

3 Administrator considers to he relevant to such rule and 

4 with respect to which the Administrator, on or before the 

5 date of the promulgation of such rule, published a notice in 

6 the Federal Register identifying such information. 

7 (b) Additional Data. — If the petitioner applies to 

8 the court for leave to adduce additional data, views, or 

9 arguments, and shows to the satisfaction of the court that 

10 such additional data, views, or arguments are material and 

11 that there are reasonable grounds for the petitioner's failure 

12 io adduce such data, views, or arguments in the proceeding 
1^ before the Administrator, the court may order the Adminis- 

trator to provide additional opportunity for oral presentation 
of data, views, or arguments and for written submissions. 
The Administrator may modify findings or determinations 
upon which the rule subject to review by such court was 
based, or make new findings or determinations by reason of 
the additional data, views, or arguments so taken and shall 
2^ file such modified or new findings or determinations, and the 
'^^ Administrator's recommendation, if any, for the modifica- 
tion or setting aside of such rule, with the return of such 
additional data, views, or arguments. 
^ (c) Authority and Review Standard,— (1) 
Upon the filing of a petition under subsection (a), the court 



384 



189 

1 shall have jurisdiction (A) to review the rule involved, in 

2 accordance with chapter 7 of title 5, United States Code, and 

3 (B) to grant appropriate relief, including interim relief, as 

4 provided in such chapter. Any rule promulgated by the Ad- 

5 ministrator under section 4, 5, or 6 of this Act and reviewed 

6 under this section shall he affirmed, unless the determination 

7 or findings required to he made hy the Administrator under 

8 the applicable section are not supported by substantial evi- 

9 dence on the record taken as a whole. 

10 (2) The judgment of the court affirming or setting aside, 

11 in whole or in part, any rule reviewed in accordance with 

12 this section shall be final, subject to review hy the Supreme 
1^ Court of the United States upon certiorari or certification, as 
1^ provided in section 1254 of title 28, United States Code. 
1^ (8) The judgment of the court in an action brought 

pursuant to subsection (a) may include an award of costs 

^'^ of suit and reasonable fees for attorneys and expert witnesses 
if the court determines that such an award is appropriate, 

19 The Supreme Court of the United States in its decision on a 

20 review of a judgment in such an action may provide for the 

21 award of costs of suit and reasonable fees for attorneys if the 

22 court determines that su^h an award is appropriate. 

23 ( d) Other Remedies, — The remedies provided in this 

24 section- shall be in addition to and not in lieu of any other 

25 remedies provided by law, . 



385 



190 

1 citizens' civil actions 

2 Sec. 20. ( a) In General.— Except as provided in 

3 subsection (b), any person may commence a civil action — 

4 (1) against any person (including (A) the United 

5 States, and (B) any other governmental instrumentality 

6 or agency to the extent permitted by the eleventh 

7 amendment to the Constitution) who is alleged to be 

8 in violation of this Act or any rule prescribed under 

9 section 4, 5, or 6(a) to restrain such violation, or 

10 (2) against the Administrator to compel the Ad- 

11 ministrator to perform any act or duty under this Act 

12 which is not discretionary. 

13 Any civil action under paragraph (1) shall be brought in the 

14 United States district court for the district in which the 
alleged violation occurred or in which the defendant resides 

1^ or in which the defendant's principal place of business is lo- 

1'^ cated. Any action brought tinder paragraph (2) shall be 
brought in the United States District Court for the District of 

19 Columbia, or the United States district court for the judicial 

20 district in which the plaintiff is domiciled. The district courts 

21 shall have jurisdiction over suits brought under this section, 

22 without regard to the amount in controversy or the citizen- 

23 ship of the parties. In any civil action under this subsection 

24 process may be served on a defendant in any judicial district 



386 



191 

1 in which the defendant resides or may be found and subpenas 

2 for witnesses may run into any judicial district. 

3 (b) Limitation,— No civil action may be com- 

4 menced — 

5 (1) under subsection (a)(1) to restrain a viola- 

6 tion of this Act or rule under this Act — 

7 (A) before the expiration of sixty days after 

8 the plaintiff has given notice of such violation (i) to 

9 the Administrator, and (ii) to the person who is 

10 alleged to have committed such violation, or 

11 (B) if the Administrator (or the Attorney 

12 General on behalf of the Administrator) has com- 
1^ menced and is diligently prosecuting a civil action 

in a court of the United States to require compli- 
ance with this Act or such rule, hut if such action 
is commenced after the giving of notice, any person 
giving such notice may intervene as a matter of 

-to 

right in such action; or 

(2) under subsection (a)(2) before the expiration 
of sixty days after the plaintiff has given notice to the 
Administrator of the alleged failure of the Administrator 
to perform an act or duty which is the basis for such 
action or, in the case of an action under such subsection 
^ for the failure of the Administrator to file an action 



387 



192 

1 under section 7, before the expiration of ten days after 

2 such notificatian. 

3 Notice under this subsection shall be given in such manner 

4 as the Administrator shall prescribe by rule. 

5 (c) General. — (1) In any action under this section, 

6 the Administrator, if not a party, may intervene as a matter 

7 of right. 

8 (2) The court, in issuing any final order in any action 

9 brough pursuant to subsection (a), may award costs of suit 

10 and reasonable fees for attorneys and expert witnesses if the 

11 court determines that such an award is appropriate. Any 

12 court, in issuing its decision in an action brought to review 

13 such an order, may award costs of suit and reasonable fees 
for attorneys if the court determines that such an award is 
appropriate. 

(3) Nothing in this section shall restrict any right 
which any person (or class of persons) may have under any 
statute or common law to seek enforcement of this Act or 
any rule under this Act or to seek any other relief. 

(d) Consolidation. — When two or more civil actions 
brought under subsection (a) involving the same defendant 
and the same issues or violations are pending in two or 
more judicial districts, such pending actions, upon applica^ 
^ tion of such defendants to such actions which is made to a 



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1 court in which any such action is brought, may, if such 

2 court in its discretion so decides, be consolidated for trial 

3 by order (issued after giving all parties reasonable notice 

4 and opportunity to be heard) of such court and tried in — 

5 (1) any district which is selected by such defend- 

6 ant and in which one of such actions is pending, 

7 (2) a district which is agreed upon by stipulation 

8 between all the parties to such actions and in which one 

9 of such actions is pending, or 

10 (3) a district which is selected by the court and 

11 in which one of such actions is pending. 

12 The court issuing such an order shall give prompt notification 

13 of the order to the other courts in which the civil actions con- 

14 solidated under the order are pending. 

15 citizens' petitions 



16 Sec. 21. (a) In General. — Any person may petition 

1'^ the Administrator to initiate a proceeding for the issuance, 

18 amendment, or repeal of a rule under section 4, 5(c), or 

19 6(a). 

20 (b) Procedures. — (1) Such petition shall be filed in 

21 the principal office of the Administrator and shall set forth 

22 the facts which it is claimed establish that it is necessary to 

23 issue, amend, or repeal a rule under section 4, 5(c), or 6(a). 

24 (2) The Administrator may hold a public hearing or 



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1 may conduct such investigation or proceeding as the Admin- 

2 istrator deems appropriate in order to determine whether or 

3 not such petition should he granted. 

4 (3) Within ninety days after filing of a petition de- 

5 scribed in paragraph (1), the Administrator shall either 

6 grant or deny the petition. If the Administrator grants such 

7 petition, the Administrator shall promptly commence an ap- 

8 propriate proceeding in accordance with section 4, 5(c), or 

9 6(a). J f the Administrator denies such petition, the Adminis- 

10 trator shall publish in the Federal Register the Administra- 

11 tors reasons for such denial. 

12 (4) (A) If the Administrator denies a petition filed 

13 under this section (or if the Administrator fails to grant or 

14 deny such petition within the ninety-day period) the peti- 

15 tioner may commence a civil action in a United States dis- 

16 trict court to compel the Administrator to initiate a rule- 

17 making proceeding to take the action requested. Any such 

18 action shall be filed vinthin sixty days after the Administra- 

19 tors denial of the petition or, if the Administrator fails to 

20 grant or deny the petition rvithin ninety days after filing 

21 the petition, within sixty days after the expiration of the 

22 ninety-day period. 

23 (B) If in an action under subparagraph (A) respect- 

24 ing a petition to initiate a proceeding to issue a rule under 

25 section 4, 5(c), or 6(a) the petitioner demonstrates to the 



390 



195 

1 satisfaction of the court, by a preponderance of the evidence 

2 in a de novo proceeding before the court, that — 

3 ( i) in the case of a petition to initiate a proceeding 

4 for the issuance of a rule under section 4, that the manu- 

5 facture, distribution in commerce, processing, use, or dis- 

6 posal of the chemical substance or mixture to be subject 

7 to such rule may cause or significantly contribute to an 

8 unreasonable risk to health or the environment, 

9 ( a) in the case of a petition to initiate a proceeding 

10 for the issuance of a rule under section 5(c), that the 

11 manufacture, processing, distribution in commerce, use, 

12 or disposal of a chemical substance petitioned to be in- 

13 eluded in a list compiled under such rule causes or sig- 

14 nificantly contributes to or may cause or significantly 

15 contribute to an unreasonable risk to health or the en- 

16 vironment, or 

17 (Hi) in the case of a petition for the issuance of a 

18 rule under section 6(a), that there is a reasonable basis 

19 to conclude that the manufacture, processing, distribution 

20 in commerce, use, or disposal of a chemical substance 

21 or mixture to be subject to such rule causes or signifi- 

22 cantly contributes to or will cause or significantly con- 

23 tribute to an unreasonable risk to health or the en- 

24 vironment, 

25 the court shall order the Administrator to initiate the action 



391 



196 

1 requested by the petitioner unless the court finds, after con- 

2 sidering the extent of the risk to health or the environment 

3 alleged by the petitioner in relation to the extent of risks to 

4 health or the environment with respect to which the Admin- 

5 istrator is taking action under this Act, the resources avail- 

6 able to the Administrator to take the action requested by the 

7 petitioner, and other relevant factors, the failure of the 

8 Administrator to initiate such action was not unreasonable. 

9 (C) The court in issuing any final order in any action 

10 brought pursuant to subparagraph (A) may award costs of 

11 suit and reasonable fees for attorneys and expert witnesses 

12 if the court determines that such an award is appropriate. 

13 Any court, in issuing its decision in an action brought to 

14 review such an order, may award costs of suit and reason- 
1*^ able fees for attorneys if the court determines that such an 
1^ award is appropriate. 

(5) The remedies under this section shall be in addi- 

1^ tion to, and not in lieu of, other remedies provided by law. 

1& NATIONAL DEFENSE WAIVER 

20 Sec. 22. The Administrator shall waive compliance 

21 with any provision of this Act upon a request and determi- 
nation by the President that the requested waiver is neces- 
sary in the interest of national de